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Assessing and Managing Sedation in the Intensive Care and the Perioperative Settings. Assessing and Managing Sedation. SEDATION Curriculum Learning Objectives. Manage adult patients who need sedation and analgesia while receiving ventilator support according to current standards and guidelines

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sedation curriculum learning objectives
SEDATION Curriculum Learning Objectives
  • Manage adult patients who need sedation and analgesia while receiving ventilator support according to current standards and guidelines
  • Use validated scales for sedation, pain, agitation and delirium in the management of these critically ill patients
  • Assess recent clinical findings in sedation and analgesia management and incorporate them into the management of patients in the acute care, procedural, and surgical sedation settings
slide4

Predisposing and Causative Conditions

Hospital

Acquired

Illness

Invasive,

Medical, &

Nursing

Interventions

Acute Medical

or Surgical Illness

Mechanical

Ventilation

Medications

Underlying

Medical

Conditions

ICU

Environmental

Influences

Anxiety Pain Delirium

Agitation

Management

of predisposing

& causative

conditions

Sedative,

analgesic,

antipsychotic,

medications

Interventions

Agitation, vent

dyssynchrony

Pain,

anxiety

Calm Alert

Free of pain and anxiety

Lightly

sedated

Deeply

sedated

Dangerous

agitation

Unresponsive

Spectrum of Distress/Comfort/Sedation

Sessler CN, Varney K. Chest. 2008;133(2):552-565.

need for sedation and analgesia
Need for Sedation and Analgesia

Prevent pain and anxiety

Decrease oxygen consumption

Decrease the stress response

Patient-ventilator synchrony

Avoid adverse neurocognitive sequelae

Depression, PTSD

Rotondi AJ, et al. Crit Care Med. 2002;30:746-752.

Weinert C. Curr Opin in Crit Care. 2005;11:376-380.

Kress JP, et al. Am J Respir Crit Care Med. 1996;153:1012-1018.

potential drawbacks of sedative and analgesic therapy
Potential Drawbacks of Sedative and Analgesic Therapy

Oversedation:

Failure to initiate spontaneous breathing trials (SBT) leads to increased duration of mechanical ventilation (MV)

Longer duration of ICU stay

Impede assessment of neurologic function

Increase risk for delirium

Numerous agent-specific adverse events

Kollef MH, et al. Chest. 1998;114:541-548.

Pandharipande PP, et al. Anesthesiology. 2006;104:21-26.

slide7

American College of Critical Care Medicine Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult

Guideline focus

Prolonged sedation and analgesia

Patients older than 12 years

Patients during mechanical ventilation

Assessment and treatment recommendations

Analgesia

Sedation

Delirium

Sleep

Update expected in 2012

Jacobi J, et al. Crit Care Med. 2002;30:119-141.

faces pain scale 0 10
FACES Pain Scale 0–10

Wong DL, et al. Wong’s Essentials of Pediatric Nursing. 6thed.

St. Louis, MO: Mosby, Inc; 2001. p.1301.

behavioral pain scale bps 3 12
Behavioral Pain Scale (BPS) 3-12

Payen JF, et al. Crit Care Med. 2001;29(12):2258-2263.

bps validation sedated mechanically ventilated patients
BPS ValidationSedated Mechanically Ventilated Patients

Is BPS Sensitive to Pain?

Is BPS Reproducible?

Weighted  = 0.74, P< 0.01

□ Not painful n = 104

● Painful n = 134

▲ Retested painful n = 31

Re-Exposed to Pain

BPS

Exposed to Pain

* P < 0.05 vs rest period

†P< 0.05 vs not painful

Payen JF, et al. Crit Care Med. 2001;29:2258–2263.

critical care pain observation tool 0 8
Critical Care Pain Observation Tool 0-8

Gélinas C, et al. Am J Crit Care. 2006;15:420-427.

critical care pain observation tool
Critical Care Pain Observation Tool

Sensitivity/Specificity DURING Painful Procedure

Gélinas C, et al. Am J Crit Care. 2006;15:420-427.

correlating pain assessment with analgesic administration in the icu
Correlating Pain Assessment withAnalgesic Administration in the ICU

Assessed

Treated

  • Fewer patients assessed for pain, more treated with analgesics in ICUs without analgesia protocols compared with ICUs with protocols1

*

Patients (%)

*

  • Pain scoring used in 21%
  • of surveyed ICUs in 20062

Protocol

No Protocol

* P < 0.01 vs ICUs using a protocol

1. Payen JF, et al. Anesthesiol. 2007;106:687-695.

2. Martin J, et al. Crit Care. 2007;11:R124.

assessing pain reduces sedative hypnotic use
Assessing Pain Reduces Sedative/Hypnotic Use

What proportion of MV ICU patients received sedative or hypnotic medication?

Payen JF, et al. Anesthesiology. 2009;111;1308-1316.

assessing pain improves some outcomes
Assessing Pain Improves Some Outcomes

Payen JF, et al. Anesthesiology. 2009;111:1308-1316.

Thromboembolic events, gastroduodenal hemorrhage, and CVC colonization were less than 10%, and not changed by pain assessment.

sedation agitation scale sas
Sedation-Agitation Scale (SAS)

Riker RR, et al. Crit Care Med. 1999;27:1325-1329.

Brandl K, et al. Pharmacotherapy. 2001;21:431-436.

richmond agitation sedation scale rass
Richmond Agitation Sedation Scale (RASS)

Verbal Stimulus

Physical Stimulus

Ely EW, et al. JAMA. 2003;289:2983-2991.

Sessler CN, et al. Am J Respir Crit Care Med. 2002;166(10):1338-1344.

sedation scale reliability
r2Kappa

SAS Riker, 1999 0.83 0.92 Brandl, 2001 0.93

RASS Sessler, 2002 0.80 Ely, 2003 0.91

Ramsay Riker, 1999 0.88 Ely, 2003 0.94 Olson, 2007 0.28

MAAS Devlin, 1999 0.83 Hogg, 2001 0.81

MSAT Weinert, 2004 0.72-0.85

Sedation Scale Reliability
correlating sedation assessment with sedative administration in the icu
Correlating Sedation Assessment withSedative Administration in the ICU
  • 1381 ICU patients included in an observational study of sedation and analgesia practices1
  • Fewer patients assessed, more treated with sedatives in ICUs without sedation protocols compared with ICUs with protocols1
  • Use of sedation protocols and scores increased between 2002 and 20062

Assessed

Treated

*

Patients (%)

*

Protocol

No Protocol

* P < 0.01 vs ICUs using a protocol

1. Payen JF, et al. Anesthesiol. 2007;106:687-695.

2. Martin J, et al. Crit Care. 2007;11:R124.

slide24

Cardinal Symptoms of Delirium and Coma

Morandi A, et al. Intensive Care Med. 2008;34:1907-1915.

icu delirium
ICU Delirium
  • Develops in ~2/3 of critically ill patients
  • Hypoactive or mixed forms most common
  • Increased risk
    • Benzodiazepines
    • Extended ventilation
    • Immobility
    • Associated with weakness
    • Undiagnosed in up to 72% of cases

Vasilevskis EE, et al. Chest. 2010;138(5):1224-1233.

slide26

Patient Factors

Increased age

Alcohol use

Male gender

Living alone

Smoking

Renal disease

Predisposing Disease

Cardiac disease

Cognitive impairment

(eg, dementia)

Pulmonary disease

Less Modifiable

  • Acute Illness
  • Length of stay
  • Fever
  • Medicine service
  • Lack of nutrition
  • Hypotension
  • Sepsis
  • Metabolic disorders
  • Tubes/catheters
  • Medications:
  • Anticholinergics
  • Corticosteroids
  • - Benzodiazepines

DELIRIUM

Environment

Admission via ED or

through transfer

Isolation

No clock

No daylight

No visitors

Noise

Use of physical restraints

More Modifiable

Van Rompaey B, et al. Crit Care. 2009;13:R77.

Inouye SK, et al. JAMA.1996;275:852-857.

Skrobik Y. Crit Care Clin. 2009;25:585-591.

sequelae of delirium
Sequelae of Delirium
  • Increased mortality
  • Longer intubation time
  • Average 10 additional days in hospital
  • Higher costs of care

During the ICU/Hospital Stay

  • Increased mortality
  • Development of dementia
  • Long-term cognitive impairment
  • Requirement for care in chronic care facility
  • Decreased functional status at 6 months

After Hospital Discharge

Bruno JJ, Warren ML. Crit Care Nurs Clin North Am. 2010;22(2):161-178.

Shehabi Y, et al. Crit Care Med. 2010;38(12):2311-2318.

Rockwood K, et al. Age Ageing. 1999;28(6):551-556.

Jackson JC, et al. Neuropsychol Rev. 2004;14:87-98.

Nelson JE, et al. Arch Intern Med. 2006;166:1993-1999.

delirium duration and mortality
Delirium Duration and Mortality

Kaplan-Meier Survival Curve

P < 0.001

Each day of delirium in the ICU increases the hazard of mortality by 10%

Pisani MA. Am J Respir Crit Care Med. 2009;180:1092-1097.

confusion assessment method cam icu
Confusion Assessment Method(CAM-ICU)

1. Acute onset of mental status changes or a fluctuating course

and

2. Inattention

and

4. Disorganized thinking

3. Altered level of

consciousness

or

= Delirium

Ely EW, et al. Crit Care Med. 2001;29:1370-1379.

Ely EW, et al. JAMA. 2001;286:2703-2710.

intensive care delirium screening checklist
Intensive Care Delirium Screening Checklist

1. Altered level of consciousness

2. Inattention

3. Disorientation

4. Hallucinations

5. Psychomotor agitation or retardation

6. Inappropriate speech

7. Sleep/wake cycle disturbances

8. Symptom fluctuation

  • Score 1 point for each component present during shift
    • Score of 1-3 = Subsyndromal Delirium
    • Score of ≥ 4 = Delirium

Bergeron N, et al. Intensive Care Med. 2001;27:859-864.

Ouimet S, et al. Intensive Care Med. 2007;33:1007-1013.

subsyndromal delirium and clinical outcomes
Subsyndromal Delirium and Clinical Outcomes

*Pairwise comparison

Ouimet S, et al. Intensive Care Med. 2007;33:1007-1013.

what to think when delirium is present
What to THINK When Delirium Is Present
  • Toxic Situations
    • CHF, shock, dehydration
    • Deliriogenic meds (Tight Titration)
    • New organ failure, eg, liver, kidney
  • Hypoxemia; also, consider giving Haloperidol or other antipsychotics?
  • Infection/sepsis (nosocomial), Immobilization
  • Nonpharmacologic interventions
    • Hearing aids, glasses, reorient, sleep protocols, music, noise control, ambulation
  • K+ or Electrolyte problems

See Skrobik Y. Crit Care Clin. 2009;25:585-591.

slide33

Oversedation

  • Prolonged mechanical ventilation
  • Increase length of stay
  • Increased risk of complications
  • - Ventilator-associated pneumonia
  • Increased diagnostic testing
  • Inability to evaluate for delirium

ICU Sedation: The Balancing Act

Patient Comfort

and Ventilatory Optimization

G

O

A

L

Undersedation

  • Patient recall
  • Device removal
  • Ineffectual mechanical ventilation
  • Initiation of neuromuscular blockade
  • Myocardial or cerebral ischemia
  • Decreased family satisfaction w/ care

Jacobi J, et al. Crit Care Med. 2002;30:119-141.

consequence of improper sedation
Consequence of Improper Sedation
  • Continuous sedation carries the risks associated with oversedation and may increase the duration of mechanical ventilation (MV)1
  • MV patients accrue significantly more cost during their ICU stay than non-MV patients2
    • $31,574 versus $12,931, P < 0.001
  • Sedation should be titrated to achieve a cooperative patient and daily wake-up, a JC requirement1,2

15.4%

30.6%

54.0%

Undersedated3

Oversedated

On Target

1. Kress JP, et al. N Engl J Med. 2000;342:1471-1477.

2. Dasta JF, et al. Crit Care Med. 2005;33:1266-1271.

3. Kaplan LJ, Bailey H.Crit Care. 2000;4(suppl 1):P190.

opioids
Opioids

Clinical Effects

Adverse Effects

  • Respiratory depression
  • Analgesia
  • Sedation
  • Hypotension
  • Bradycardia
  • Constipation
  • Tolerance

Fentanyl

  • Withdrawal symptoms
  • Hormonal changes

Morphine

Remifentanil

Benyamin R, et al. Pain Physician. 2008;11(2 Suppl):S105-120.

opioid mechanisms
Opioid Mechanisms

Neurotransmitters

ACh Acetylcholine

Glu Glutamate

NE Norepinephrine

Brown EN, et al. N Engl J Med. 2010;363(27):2638-2650.

analgosedation
Analgosedation

Analgesic first (A-1), supplement with sedative

Acknowledges that discomfort may cause agitation

Remifentanil-based regimen

Reduces propofol use

Reduces median MV time

Improves sedation-agitation scores

Not appropriate for drug or alcohol withdrawal

Park G, et al. Br J Anaesth. 2007;98:76-82.

Rozendaal FW, et al. Intensive Care Med. 2009;35:291-298.

analgosedation1
Analgosedation
  • 140 critically ill adult patients undergoing mechanical ventilation in single center
  • Randomized, open label trial
    • Both groups received bolus morphine (2.5 or 5 mg)
    • Group 1: No sedation (n = 70 patients)- morphine prn
    • Group 2: Sedation (20 mg/mL propofol for 48 h, 1 mg/mL midazolam thereafter) with daily interruption until awake (n = 70, control group)
  • Endpoints
    • Primary
      • Number of days without mechanical ventilation in a 28-day period
    • Other
      • Length of stay in ICU (admission to 28 days)
      • Length of stay in hospital (admission to 90 days)

Strøm T, et al. Lancet. 2010;375:475-480.

analgosedation intervention
Analgosedation Intervention

Morphine prn at 2.5 or 5 mg for comfort

Physician consult if patient seemed uncomfortable

Haloperidol prnfor delirium

If still uncomfortable, propofol infusion for 6 hours Transitioned back to prn morphine

Strøm T, et al. Lancet. 2010;375:475-480.

analgosedation results
AnalgosedationResults
  • Patients receiving no sedation had
    • More days without ventilation (13.8 vs 9.6 days, P = 0.02)
    • Shorter stay in ICU (HR 1.86, P = 0.03)
    • Shorter stay in hospital (HR 3.57, P = 0.004)
    • More agitated delirium (N = 11, 20% vs N = 4, 7%, P = 0.04)
  • No differences found in
    • Accidental extubations
    • Need for CT or MRI
    • Ventilator-associated pneumonia

Strøm T, et al. Lancet. 2010;375:475-480.

characteristics of an ideal sedative
Characteristics of an Ideal Sedative

Rapid onset of action allows rapid recovery after discontinuation

Effective at providing adequate sedation with predictable dose response

Easy to administer

Lack of drug accumulation

Few adverse effects

Minimal adverse interactions with other drugs

Cost-effective

Promotes natural sleep

1. Ostermann ME, et al. JAMA. 2000;283:1451-1459.

2. Jacobi J, et al. Crit Care Med. 2002;30:119-141.

3. Dasta JF, et al. Pharmacother. 2006;26:798-805.

4. Nelson LE, et al. Anesthesiol. 2003;98:428-436.

consider patient comorbidities when choosing a sedation regimen
Consider Patient Comorbidities When Choosing a Sedation Regimen
  • Chronic pain
  • Organ dysfunction
  • CV instability
  • Substance withdrawal
  • Respiratory insufficiency
  • Obesity
  • Obstructive sleep apnea
slide44

GABA Agonist

Benzodiazepine Midazolam

Clinical Effects

Adverse Effects

  • Sedation, anxiolysis, and amnesia
  • Rapid onset of action (IV)
  • May accumulate with hepatic and/or renal failure
  • Anterograde amnesia
  • Long recovery time
  • Synergy with opioids
  • Respiratory depression
  • Delirium

Olkkola KT, Ahonen J. Handb Exp Pharmacol. 2008;(182):335-360.

Riker RR, et al; SEDCOM Study Group. JAMA. 2009;301(5):489-499.

midazolam pharmacodynamics it s about time
Midazolam Pharmacodynamics: It’s About Time
  • Highly lipid soluble
  • α-OH midazolam metabolite
  • CYP3A4 activity decreased in critical illness
  • Substantial CYP3A4 variability

60

50

40

Time to Endpoint (h)

Extubation

30

Alertness Recovery

20

10

0

Sedation Time (days)

< 1

1-7

> 7

Carrasco G, et al. Chest. 1993;103:557-564.

Bauer TM, et al. Lancet. 1995;346:145-147.

slide46

GABA Agonist

Benzodiazepine Lorazepam

  • Adverse Effects
  • Metabolic acidosis (propylene glycol vehicle toxicity)
  • Retrograde and anterograde amnesia
  • Delirium

Clinical Effects

  • Sedation, anxiolysis, and amnesia
  • Commonly used for long-term sedation

Olkkola KT, Ahonen J. Handb Exp Pharmacol. 2008;(182):335-360.

Wilson KC, et al. Chest. 2005;128(3):1674-1681.

risk of delirium with benzodiazepines
Risk of Delirium With Benzodiazepines

Delirium Risk

Lorazepam Dose, mg

Pandharipande P, et al. J Trauma. 2008;65:34-41. Pandharipande P, et al. Anesthesiol. 2006:104:21-26.

gaba agonist propofol
GABA Agonist Propofol

Clinical Effects Adverse Effects

  • Sedation
  • Hypnosis
  • Anxiolysis
  • Muscle relaxation
  • Mild bronchodilation
  • Decreased ICP
  • Decreased cerebral metabolic rate
  • Antiemetic
  • Pain on injection
  • Respiratory depression
  • Hypotension
  • Decreased myocardial contractility
  • Increased serum triglycerides
  • Tolerance
  • Propofol infusion syndrome
  • Prolonged effect with high adiposity
  • Seizures (rare)

Ellett ML. Gastroenterol Nurs. 2010;33(4):284-925.

Lundström S, et al. J Pain Symptom Manage. 2010;40(3):466-470.

central mechanisms of propofol
Central Mechanisms of Propofol

Monoaminergic pathways

Cholinergic pathways

Lateral hypothalamus neurons

Neurotransmitters

ACh Acetylcholine

DA Dopamine

GABA γ-Aminobutyric acid

GAL Galanin

Glu Glutamate

His Histamine

NE Norepinephrine

5HT Serotonin

Brown EN, et al. N Engl J Med. 2010;363(27):2638-2650.

slide50

Propofol Has Greater Sedation Efficacy

Than Continuous Midazolam

Duration of

Adequate Sedation

Efficacy of Sedation*

n = 18 trials

n = 15 trials

* Avg adequate sedation time

avg total sedation time

Walder B, et al. Anesth Analg. 2001;92:975-983.

slide51

Continuous Midazolam Has Longer

Weaning Time From MV Than Propofol

Data from 8 RCT

Walder B, et al. Anesth Analg. 2001;92:975-983.

scheduled intermittent lorazepam vs propofol with daily interruption in micu patients
Scheduled Intermittent Lorazepam vs Propofol with Daily Interruption in MICU Patients

Lorazepam

n = 64

Propofol

n = 68

P value

Ventilator days

8.4

5.8

0.04

ICU LOS

10.4

8.3

0.20

APACHE II

22.9

20.7

0.05

Daily sedation dose

11.5 mg

24.4 mcg/kg/min

_

Morphine dose (mg/day)

10.7

31.6

0.001

Use of haloperidol

12%

9%

0.80

Carson SS, et al. Crit Care Med. 2006;34:1326-1332.

a 2 agonist clonidine
a2Agonist Clonidine

Clinical Effects

Adverse Effects

  • Antihypertensive
  • Analgesia
  • Sedation
  • Decrease sympathetic activity
  • Decreased shivering
  • Bradycardia
  • Dry mouth
  • Hypotension
  • Sedation

Kamibayashi T, et al. Anesthesiol. 2000;93:1345-1349.

Bergendahl H, et al. Curr Opin Anaesthesiol. 2005;18(6):608-613.

Hossmann V, et al. Clin Pharmacol Ther. 1980;28(2):167-176.

slide54

Physiology of a2Adrenoceptors

a2A

Anxiolysis

a2A

a2C

X

? a2B

a2A

a2B

X

a2A

?

a2B

Adapted from Kamibayashi T, Maze M. Anesthesiology. 2000;93:1346-1349.

a 2 agonist dexmedetomidine
a2Agonist Dexmedetomidine

Adverse Effects

Clinical Effects

  • Antihypertensive
  • Sedation
  • Analgesia
  • Decreased shivering
  • Anxiolysis
  • Patient arousability
  • Potentiate effects of opioids,
  • sedatives, and anesthetics
  • Decrease sympathetic activity
  • Hypotension
  • Hypertension
  • Nausea
  • Bradycardia
  • Dry mouth
  • Peripheral vasoconstriction at high doses

Kamibayashi T, et al. Anesthesiol. 2000;93:1345-1349.

Bhana N, et al. Drugs. 2000;59(2):263-268.

central mechanisms of dexmedetomidine
Central Mechanisms of Dexmedetomidine
  • Neurotransmitters
  • ACh Acetylcholine
  • DA Dopamine
  • GABA γ-Aminobutyric acid
  • GAL Galanin
  • Glu Glutamate
  • His Histamine
  • NE Norepinephrine
  • 5HT Serotonin

Brown EN, et al. N Engl J Med. 2010;363(27):2638-2650.

maximizing efficacy of targeted sedation and reducing neurological dysfunction mends
Maximizing Efficacy of Targeted Sedation and Reducing Neurological Dysfunction (MENDS)

Double-blind RCT of dexmedetomidine vs lorazepam

103 patients (2 centers)

70% MICU, 30% SICU patients (requiring mechanical ventilation > 24 hours)

Primary outcome: Days alive without delirium or coma

Intervention

Dexmedetomidine 0.15–1.5 mcg/kg/hr

Lorazepam infusion 1–10 mg/hr

Titrated to sedation goal (using RASS) established by ICU team

No daily interruption

Pandharipande PP, et al. JAMA. 2007;298:2644-2653.

mends dexmedetomidine vs lorazepam
MENDS: Dexmedetomidine vs Lorazepam

Dexmedetomidine resulted in more days alive without delirium or coma (P = 0.01) and a lower prevalence of coma (P < 0.001) than lorazepam

Dexmedetomidine resulted in more time spent within sedation goals than lorazepam (P = 0.04)

Differences in 28-day mortality and delirium-free days were not significant

P = 0.011

P = 0.086

P < 0.001

12

10

8

Days

6

4

2

Dexmedetomidine n = 52

0

Lorazepam n = 51

Delirium/Coma-Free

Days

Delirium-Free

Days

Coma-Free

Days

Pandharipande PP, et al. JAMA. 2007;298:2644-2653.

slide59

MENDS Delirium: All Patients

Pandharipande PP, et al. Crit Care. 2010;14:R38.

mends survival in septic icu patients
MENDS: Survival in Septic ICU Patients

Pandharipande PP, et al. Crit Care. 2010;14:R38.

slide61

MENDS Trial: Safety Profile

Outcome

Lorazepam

(n = 50)

Dexmedetomidine

(n = 51)

P-Value

Lowest SBP

97 (88,102)

96 (88,105)

0.58

Ever hypotensive (SBP < 80)

20%

25%

0.51

Days on vasoactive meds

0 (0,3)

0 (0,2)

0.72

Sinus bradycardia (< 60/min)

4%

17%

0.03

Heart rate < 40

2%

2%

0.99

Self-extubations (reintubations)

2 (2)

4 (3)

0.41

Pandharipande PP, et al. JAMA. 2007;298:2644-2653.

slide62

SEDCOM:

Dexmedetomidine vs Midazolam

  • Double-blind, randomized, multicenter trial comparing long-term (> 24 hr) dexmedetomidine (dex, n = 244) with midazolam (mz, n = 122)
  • Sedatives (dex 0.2-1.4 μg/kg/hr or mz 0.02-0.1 mg/kg/hr) titrated for light sedation (RASS -2 to +1), administered up to 30 days
  • All patients underwent daily arousal assessments and drug titration Q 4 hours

P-Value

Outcome

Midazolam

(n = 122)

Dexmedetomidine

(n = 244)

Time in target sedation range, % (primary EP)

75.1

77.3

0.18

Duration of sedation, days

4.1

3.5

0.01

Time to extubation, days

5.6

3.7

0.01

Delirium prevalence

93 (76.6%)

132 (54%)

0.001

Delirium-free days

1.7

2.5

0.002

Patients receiving open-label midazolam

60 (49%)

153 (63%)

0.02

Riker RR, et al. JAMA. 2009;301:489-499.

reduced delirium prevalence with dexmedetomidine vs midazolam sedcom
Reduced Delirium Prevalence with Dexmedetomidine vs MidazolamSEDCOM

Midazolam

Dexmedetomidine

Sample Size

118 229

109 206

92 175

77 134

57 92

42 60

44 34

100

Dexmedetomidine versus Midazolam, P < 0.001

80

60

Patients With Delirium, %

40

20

0

Baseline

1

2

3

4

5

6

Treatment Day

Riker RR, et al. JAMA. 2009;301:489-499.

sedcom trial safety outcomes
SEDCOM Trial:Safety Outcomes

Tachycardia

44.3%

25.4%

0.001

Hypertension requiring intervention

29.5%

18.9%

0.02

Hyperglycemia

42.6%

56.6%

0.02

Infections

19.7%

10.2%

0.02

Outcome

Midazolam

(n = 122)

Dexmedetomidine

(n = 244)

P-Value

Bradycardia

18.9%

42.2%

0.001

Bradycardia needing treatment 0.8% 4.9% 0.07

Riker RR, et al. JAMA. 2009;301:489-499.

comparison of clinical effects
Comparison of Clinical Effects

Benzodiazepines

Propofol

Opioids

a2 Agonists

Haloperidol

Sedation

X

X

X

X

X

Alleviate anxiety1,2

X

X

Analgesic properties1-4

X

X

Promote arousability during sedation2-4

X

Facilitate ventilation during weaning2-4

X

X

Control delirium1-4

X

X

1. Blanchard AR. Postgrad Med. 2002;111:59-74.

2. Kamibayashi T, et al. Anesthesiol. 2000;95:1345-1349.

3. Maze M, et al. Anesthetic Pharmacology: Physiologic Principles and

Clinical Practice. Churchill Livingstone; 2004.

4. Maze M, et al. Crit Care Clin. 2001;17:881-897.

comparison of adverse effects
Comparison of Adverse Effects

a2 Agonists

Benzodiazepines

Propofol

Opioids

Haloperidol

Prolonged weaning 1

X

X

X *

Respiratory depression 1

X

X

X

Hypotension 1-3

X

X

X

X

X

Constipation 1

X

X

Deliriogenic

X

X

Tachycardia 1

morphine

Bradycardia 1

fentanyl

X

X

X

*Excluding remifentanil

1. Harvey MA. Am J Crit Care. 1996;5:7-18.

2. Aantaa R, et al. Drugs of the Future. 1993;18:49-56.

3. Maze M, et al. Crit Care Clin. 2001;17:881-897.

costs of drug therapy
Costs of Drug Therapy

Acquisition

Waste disposal

Preparation

Distribution

Administration (Nursing time)

Toxicity cost (ADRs)

Monitoring (Time, lab, and diagnostic tests)

Downstream issues (infections, adverse events, ICU stay, ventilator time, etc)

Dasta JF, Kane-Gill S. Crit Care Clin. 2009;25:571-583.

drug acquisition cost 70 kg patient per day
Drug Acquisition Cost(70 kg patient, per day)

Lorazepam 3 mg/hr: $35

Midazolam 5 mg/hr $42

Propofol 30 mcg/kg/min: $150

Dexmedetomidine 0.5 mcg/kg/hr: $274

Tufts Medical Center 2009 Pricing

slide69

Propofol Is More Cost-Effective Than Lorazepam

Propofol less expensive

2

0.5

`

Low

High

Lorazepam more

effective

$1,825

$9,488

75%

5%

$631

$1,892

20%

0%c

20%

0%

Lorazepam

Midazolam

Low

High

$11.37

$60.77

4,347

949

$0.81

$7.82

23

4

$35

$10

$15

$20

$25

$30

-$5

$0

$5

-$10

-$35

-$30

-$25

-$20

-$15

Cost Difference Between Lorazepam and Propofol ($ Thousands)

Cox CE, et al. Crit Care Med. 2008;36:706-714.

mends trial cost of care
MENDS Trial: Cost of Care

Component

Lorazepam

Dexmedetomidine

P-value

Pharmacy

20.6 (10,42)

27.4 (16,46)

0.15

Respiratory

2.9 (2,6)

3.5 (2,7)

0.35

ICU cost

59.5 (36,83)

61.4 (37,108)

0.32

$ – Costs represented in thousands, US dollars (Median, IQR)

Pandharipande PP, et al. JAMA. 2007;298:2644-2653.

sedcom cost of care
SEDCOM Cost of Care
  • Median drug costs
    • Dex $1,166
    • Midazolam $60
  • Total ICU patient savings with Dex: $9679
    • Reduced ICU stay
    • Reduced MV

P < 0.01

P < 0.05

P < 0.01

Dasta JF, et al. Crit Care Med. 2010;38:497-503.

slide72
Strategies to Reduce the Duration of Mechanical Ventilation in Patients Receiving Continuous Sedation
nurse driven sedation protocol
Nurse-Driven Sedation Protocol

RCT of RN-driven protocol vs non-protocol sedation care in 321 MICU patients requiring mechanical ventilation

The protocol:

Assess pain first

Correct other etiologies for agitation

Use a sedation score to titrate sedatives

Use intermittent sedation first

Actively down-titrated sedation even when patient was at “goal”

Brook AD, et al Crit Care Med. 1999;27:2609-2615.

pharmacist driven sedation protocol
Pharmacist-Driven Sedation Protocol

156 MICU patients prescribed continuous sedation

Protocol encouraged 25% down-titration when patients more sedated than goal

Before/after design evaluating impact of pharmacist promoting protocol on at least a daily basis

Median Days of Mechanical Ventilation

10

P < 0.001

9

8

7

6

6.9

5

4

5.2

3

2

1

0

Pharmacist-Led

Control

Marshall J, et al. Crit Care Med. 2008;36:427-433.

daily sedation interruption decreases duration of mechanical ventilation
Daily Sedation Interruption Decreases Duration of Mechanical Ventilation

Hold sedation infusion until patient awake and then restart at 50% of the prior dose

“Awake” defined as 3 of the following 4:

Open eyes in response to voice

Use eyes to follow investigator on request

Squeeze hand on request

Stick out tongue on request

  • Fewer diagnostic tests to assess changes in mental status
  • No increase in rate of agitated-related complications or
  • episodes of patient-initiated device removal
  • No increase in PTSD or cardiac ischemia

Kress JP, et al. N Engl J Med. 2000;342:1471-1477.

abc trial objectives
To determine the efficacy and safety of a protocol linking:

spontaneous awakening trials (SATs) &

spontaneous breathing trials (SBTs)

Ventilator-free days

Duration of mechanical ventilation

ICU and hospital length of stay

Duration of coma and delirium

Long-term neuropsychological outcomes

ABC Trial: Objectives

Girard TD, et al. Lancet. 2008;371:126-134.

abc trial main outcomes
ABC Trial: Main Outcomes

Outcome*

SBT

SAT+SBT

P-value†

12

15

0.02

Ventilator-free days

Time-to-Event, days

Successful extubation

7.0

5

0.05

ICU discharge

13

9

0.02

Hospital discharge

19

15

0.04

Death at 1 year, n (%)

97 (58%)

74 (44%)

0.01

Days of brain dysfunction

Coma

3.0

2.0

0.002

Delirium

2.0

2.0

0.50

*Median, except as noted

†SBT compared with SAT+SBT

Girard TD, et al. Lancet. 2008;371:126-134.

abc trial 1 year follow up
ABC Trial: 1 Year Follow-Up

Girard TD, et al. Lancet. 2008;371:126-134.

slide79
Despite Proven Benefits of Spontaneous Awakening/Daily Interruption Trials, They Are Not Standard of Practice at Most Institutions

Canada– 40% get SATs (273 physicians in 2005)1

US– 40% get SATs (2004-05)2

Germany – 34% get SATs (214 ICUs in 2006)3

France – 40–50% deeply sedated with 90% on

continuous infusion of sedative/opiate4

1. Mehta S, et al. Crit Care Med. 2006;34:374-380.

2. Devlin J. Crit Care Med. 2006;34:556-557.

3. Martin J, et al. Crit Care. 2007;11:R124.

4. Payen JF, et al. Anesthesiology. 2007;106:687-695.

slide80

Barriers to Daily Sedation Interruption

(Survey of 904 SCCM members)

Increased device removal

Poor nursing acceptance

Compromises patient comfort

Leads to respiratory compromise

Difficult to coordinate with nurse

No benefit

#1 Barrier

Leads to cardiac ischemia

#2 Barrier

#3 Barrier

Leads to PTSD

0

10

20

30

40

50

60

70

Number of respondents (%)

Clinicians preferring propofol were more likely use daily interruption

than those preferring benzodiazepines (55% vs 40% , P < 0.0001)

Tanios MA, et al. J Crit Care. 2009;24:66-73.

early mobilization trial design
Early Mobilization Trial Design
  • 104 sedated patients with daily interruption
    • Early exercise and mobilization (PT & OT; intervention; n = 49)
    • PT & OT as ordered by the primary care team (control; n = 55)
  • Primary endpoint: Number of patients returning to independent functional status at hospital discharge
    • Ability to perform 6 activities of daily living
    • Ability to walk independently
  • Assessors blinded to treatment assignment
  • Secondary endpoints
    • Duration of delirium during first 28 days of hospital stay
    • Ventilator-free days during first 28 days of hospital stay

Schweickert WD, et al. Lancet. 2009;373:1874-1882.

slide82

Early Mobilization Protocol: Result

  • Return to independent functional status at discharge
  • 59% in intervention group
  • 35% in control group (P = 0.02)

Schweickert WD, et al. Lancet. 2009;373:1874-1882.

slide83

Animation = Less Delirium

Variable

Intervention

(n = 49)

Control

(n = 55)

P-Value

ICU/Hosp Delirium (days)

2

4

0.03

Time in ICU with Delirium

33%

57%

0.02

Time in Hosp. with Delirium

28%

41%

0.01

Schweickert WD, et al. Lancet. 2009;373:1874-1882.

procedural sedation major applications
Procedural SedationMajor Applications
  • Surgical
    • CV surgery
    • Neurosurgery
    • Bariatric surgery
  • Endoscopic
    • Bronchoscopy
    • Fiberoptic intubation
    • Colonoscopy
standardized monitoring
Standardized Monitoring
  • Hemodynamic
    • ECG
    • Blood pressure
  • Respiration
    • Oxygenation (SpO2 by pulse oximetry, supplemental oxygen)
    • Ventilation (end tidal CO2, EtCO2)
  • Temperature (risk of hypothermia)
  • Higher risk at remote locations
    • Inadequate oxygenation/ventilation
    • Oversedation
    • Inadequate monitoring

Eichhorn V, et al. Curr Opin Anaesthesiol. 2010;23(4):494-499.

factors jeopardizing safety
Factors Jeopardizing Safety
  • Risk of major blood loss
  • Extended duration of surgery (> 6 h)
  • Critically ill patients (evaluate and document prior to procedure)
  • Need for specialized expertise or equipment (cardio-pulmonary bypass, thoracic or intracranial surgery)
  • Supply and support functions or resources are limited
  • Inadequate postprocedural care
  • Physical plant is inappropriate or fails to meet regulatory standards

Eichhorn V, et al. Curr Opin Anaesthesiol. 2010;23(4):494-499.

sedation analgesia for traumatic brain injury
Sedation/Analgesia for Traumatic Brain Injury

Goal: reduce ICP by decreasing pain, agitation

Saiki RL. Crit Care Nurs Clin North Am. 2009;21:549-559.

fentanyl vs dexmedetomidine in bariatric surgery
20 morbidly obese patients

Roux-en-Y gastric bypass surgery

All received midazolam, desflurane to maintain BIS at 45–50, and intraoperative analgesics

Fentanyl (n = 10) 0.5 µg/kg bolus, 0.5 µg/kg/h

Dexmedetomidine (n = 10) 0.5 µg/kg bolus, 0.4 µg/kg/h

Dexmedetomidine associated with

Lower desflurane requirement for BIS maintenance

Decreased surgical BP and HR

Lower postoperative pain and morphine use (up to 2 h)

Fentanyl vs Dexmedetomidine in Bariatric Surgery
  • Feld JM, et al. J Clin Anesthesia. 2006;18:24-28.
dexmedetomidine in bariatric surgery
Dexmedetomidine in Bariatric Surgery
  • 80 morbidly obese patients
  • Gastric banding or bypass surgery
  • Prospective dose ranging study
  • Medication
    • Celecoxib 400 mg po
    • Midazolam 20 µg/kg IV
    • Propofol 1.25 mg/kg IV
    • Desflurane 4% inspired
    • Dexmedetomidine 0, 0.2, 0.4, 0.8 µg/kg/h IV

Tufanogullari B, et al. Anesth Analg. 2008;106:1741-1748.

dexmedetomidine in bariatric surgery results
Dexmedetomidine in Bariatric Surgery: Results
  • More dex 0.8 patients required rescue phenylephrine for hypotension than control pts (50% vs 20%, P < 0.05)
  • All dex groups
    • Required less desflurane (19%–22%)
    • Had lower MAP for 45’ post-op
    • Required less fentanyl after awakening (36%–42%)
    • Had less emetic symptoms post-op
  • No clinical difference
    • Emergence from anesthesia
    • Post-op self-administered morphine and pain scores
    • Length of stay in post-anesthesia care unit
    • Length of stay in hospital

Tufanogullari B, et al. Anesth Analg. 2008;106:1741-1748.

sedation for endoscopy
Sedation for Endoscopy
  • Desirable qualities
    • Permits complete diagnostic exam
    • Safe
    • Diminishes memory of the procedure
    • Permits rapid discharge after procedure
  • Risk factors
    • Depth of sedation
    • ASA status
    • Medical conditions
    • Pregnancy
    • Difficult airway mgt
    • Extreme age
    • Rapid discharge time

Runza M. Minerva Anestesiol. 2009;75:673-674.

propofol vs combined sedation in flexible bronchoscopy
Propofol vs Combined Sedationin Flexible Bronchoscopy
  • Randomized non-inferiority trial
  • 200 diverse patients received propofol or midazolam/hydrocodone
  • 1o endpoints
    • Mean lowest SaO2
    • Readiness for discharge at 1h
  • Result
    • No difference in mean lowest SaO2
    • Propofol group had
      • Higher readiness for discharge score (P = 0.035)
      • Less tachycardia
      • Higher cough scores
  • Conclusion: Propofol is a viable alternative to midazolam/ hydrocodone for FB

Stolz D, et al. Eur Respir J. 2009;34:1024-1030.

fiberoptic intubation
Fiberoptic Intubation

Summary courtesy of Pratik Pandharipande, MD.

before considering a pharmacologic treatment for delirium
Before Considering a Pharmacologic Treatment for Delirium…
  • Have the underlying causes of delirium been identified and reversed/treated?
  • Have non-pharmacologic treatment strategies been optimized?
  • Does your patient have delirium?
    • Hyperactive
    • Hypoactive
    • Mixed hyperactive-hypoactive

Inouye SK, et al. N Engl J Med. 1999;340:669-676.

dopamine antagonist haloperidol
Dopamine Antagonist Haloperidol

Clinical Effects

Adverse Effects

  • Hypnotic agent with antipsychotic properties1
  • Dysphoria2
  • Adverse CV effects include QT interval prolongation
  • For treatment of delirium in critically ill adults1
  • Extrapyramidal symptoms, neuroleptic malignant syndrome (rare)1
  • Does not cause respiratory depression1
  • Metabolism altered by drug-drug interactions2

1. Harvey MA. Am J Crit Care. 1996;5:7-16.

2. Crippen DW. Crit Care Clin. 1990;6:369-392.

slide97

Use of Haloperidol Is an Independent Predictor for Prolonged Delirium

Pisani MA, et al. Crit Care Med. 2009;37:177-183.

potential advantages of atypical antipsychotics vs conventional antipsychotics
Potential Advantages of Atypical Antipsychotics vs Conventional Antipsychotics

Decreased extrapyramidal effects

Little effect on the QTc interval (with the exception of ziprasidone)

Less hypotension/fewer orthostatic effects

Less likely to cause neuroleptic malignant syndrome

Unlikely to cause laryngeal dystonia

Lower mortality when used in the elderly to treat agitation related to dementia

Tran PV, et al. J Clin Psychiatry. 1997;58:205-211.

Lee PE, et al. J Am Geriatr Soc. 2005;53:1374-1379.

Wang PS, et al. N Engl J Med. 2005;353:2235-2341.

use of atypical antipsychotic therapy is increasing
Use of Atypical Antipsychotic Therapy Is Increasing

90

80

70

60

2001

50

2007

40

30

20

10

0

Propofol

Haloperidol

Benzodiazepines

Atypical anti-psychotics

Ely EW, et al. Crit Care Med. 2004;32:106-112.

Patel RP, et al. Crit Care Med. 2009;37:825-832.

slide100

Antipsychotic Therapy

Rule Out Dementia

  • Elderly patients with dementia-related psychosis treated with conventional or atypical antipsychotic drugs are at an increased risk of death
  • Antipsychotic drugs are not approved for the treatment of dementia-related psychosis. Furthermore, there is no approved drug for the treatment of dementia-related psychosis
  • Physicians who prescribe antipsychotics to elderly patients with dementia-related psychosis should discuss this risk of increased mortality with their patients, patients’ families, and caregivers

http://www.canhr.org/ToxicGuide/Media/Articles/FDA%20Alert%20on%20Antipsychotics.pdf

drug specificity comparative receptor binding profiles

D1

D2

D1

D2

5HT2A

5HT1A

5HT2A

M

A1

H1

A1

A2

A2

H1

D1

H1

A1

D1

D2

D2

A2

D1

A1

5HT1A

A1

5HT1A

5HT1A

5HT2A

D2

5HT2A

5HT2A

Drug Specificity:Comparative Receptor Binding Profiles

Quetiapine

Olanzapine

Ziprasidone

Risperidone

Haloperidol

Adapted from Gareri P, et al. Clin Drug Invest. 2003;23:287-322.

rationale based pharmacotherapy important principles

Receptors

Effects of Receptor Blockade

H1

Sedation, weight gain, postural dizziness

D2

EPS, prolactin elevation, antipsychotic

5-HT2C

Satiety blockade

5-HT2A

Anti-EPS?

α1-adrenergic

Hypotension

M1

Deficits in memory and cognition, dry mouth, constipation, tachycardia, blurred vision

Rationale-based PharmacotherapyImportant Principles

Adapted from Weiden P, et al. J Clin Psychiatry. 2007;68:5-46.

m odifying the in cidence of d elirium mind trial
Design: Double-blind, placebo-controlled, randomized trial

Setting: 6 tertiary medical centers

Intervention:

Haloperidol (5 mg) vs ziprasidone (40 mg) vs placebo

Max 14 days

Dose interval increased if CAM-ICU negative

Could give IM if NPO up to max 8 doses

Oversedation: ↓dose frequency when RASS ≥ 2 levels above target (after holding sedation therapy)

If delirium reoccurred after d/c of study drug then restarted at last effective dose (and weaned again as per above)

Primary outcome:

Number of days patient alive without delirium or coma during the 21-day study period

Delirium = + CAM-ICU

Coma = RASS (-4) [ie, responsive to physical but not verbal stimulation] or RASS (-5) [ie, not responsive to either]

Modifying the Incidence of Delirium (MIND) Trial

Girard TD, et al. Crit Care Med. 2010;38:428-437.

slide104

MIND Trial Results

Outcome

Haloperidol, n = 35

Ziprasidone,

n = 30

Placebo,

n = 36

P-value

Delirium/coma-free days

14.0

15.0

12.5

0.66

Delirium days

4

4

4

0.93

Delirium resolution on study drug, n(%)

24 (69)

23 (77)

21 (58)

0.28

Coma days

2

2

2

0.90

% of days accurately sedated

70

64

71

0.91

Ventilator-free days

7.8

12.0

12.5

0.25

Length of stay, days

ICU

Hospital

11.7

13.8

9.6

13.5

7.3

15.4

0.70

0.68

21-day mortality, n (%)

4 (11)

4 (13)

6 (17)

0.81

Average extrapyramidal symptoms score

0

0

0

0.56

Girard TD, et al. Crit Care Med. 2010;38:428-437.

slide105
Double-blind, placebo-controlled, randomized trial

3 academic medical centers

Intervention

Quetiapine 50 mg PO/NGT twice daily titrated to a maximum of 200 mg twice daily) vs placebo

PRN IV haloperidol protocolized and encouraged in each group

Oversedation: hold study drug when SAS ≤ 2 (after holding sedation therapy)

Primary outcome

Time to first resolution of delirium (ie, first 12-hour period when ICDSC ≤ 3)

Quetiapine for DeliriumStudy Design

Devlin JW, et al. Crit Care Med. 2010;38:419-427.

slide106

258 patients with delirium (ICDSC ≥ 4) tolerating enteral nutrition

222 patients excluded

36 subjects randomized

Quetiapine 50 mg NG bid

(n = 18)

Placebo 50 mg NG bid

(n = 18)

As-needed haloperidol, usual sedation and analgesia

therapy at physician’s discretion

Dose Titration

Increase quetiapine or placebo dose by 50 mg every 12 hours daily

if the subject received ≥ 1 dose of as needed haloperidol in prior 24 hours.

(Maximum dose = 200 mg every 12 hours)

  • Discontinuation of study drug
  • No signs of delirium
  • 10 days of therapy had elapsed
  • 3. ICU discharge prior to 10 days of therapy
  • 4. Serious adverse event potentially attributable to the study drug

Devlin JW, et al. Crit Care Med. 2010;38:419-427.

slide107

Patients with First Resolution of Delirium

Log-Rank

P = 0.001

Proportion of Patients with Delirium

Placebo

Quetiapine

Day During Study Drug Administration

Quetiapine added to as-needed haloperidol results in faster delirium resolution, less agitation, and a greater rate of transfer to home or rehabilitation.

Devlin JW, et al. Crit Care Med. 2010;38:419-427.

sleep abnormalities in the icu
Sleep Abnormalities in the ICU

% time in light sleep increased

(NREM stages 1 and 2)

% time in deep sleep decreased

[slow wave sleep (SWS) and

REM sleep)

Sleep fragmentation increased

Friese R. Crit Care Med. 2008;36:697-705.

Weinhouse GL, Watson PL. Crit Care Clin. 2009;25:539-549.

effect of common sedatives and analgesics on sleep
Effect of Common Sedatives and Analgesics on Sleep

There is little evidence that administration of sedatives in

the ICU achieves the restorative function of normal sleep

  • Benzodiazepines

↑ Stage 2 NREM

↓ Slow wave sleep (SWS) and REM

  • Propofol

↑ Total sleep time without enhancing REM

↓ SWS

  • Analgesics
    • Abnormal sleep architecture
  • Dexmedetomidine

↑ SWS

Weinhouse GL, et al. Sleep. 2006;29:707-716.

Nelson LE, et al. Anesthesiology. 2003;98:428-436.

strategies to boost sleep quality in the icu
Strategies to Boost Sleep Quality in the ICU

Weinhouse GL, Watson PL. Crit Care Clinics. 2009;25:539-549.

Faulhaber J, et al. Psychopharmacology. 1997;130:285-291.

Shilo L, et al. Chronobiol Int. 2000;17:71-76.

Optimize environmental strategies

Avoid benzodiazepines

Consider dexmedetomidine

Zolpidem and zopiclone are GABA receptor agonists but do not decrease SWS like the benzodiazepines

Sedating antidepressants (eg, trazodone) or antipsychotics may offer an option in non-intubated patients

Melatonin may improve sleep of COPD patients in medical ICU (1 small RCT)

Don’t disturb sleeping patients at night

american college of critical care medicine accm guidelines
American College of Critical Care Medicine (ACCM) Guidelines
  • Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult
  • Pertains to patients older than 12 years during M V
  • Areas of focus
    • Assessment for pain, delirium
    • Physiological monitoring
    • Pharmacologic tools
  • Most recommendations grade B or C

Jacobi J, et al. Crit Care Med. 2002;30:119-141.

conclusions
Conclusions

Oversedation in the ICU is common; associated with negative sequelae

Monitor and treat pain and delirium prior to administering sedation therapy

Analgosedation has been shown to improve outcomes; consider sedation only if necessary

Titrate all sedative medications using a validated assessment tool to keep patients comfortable and arousable if possible

Monitor for adverse events

conclusions1
Conclusions

ICU sedation should use protocols that include a down-titration and/or daily interruption strategy coupled with a spontaneous breathing trial

Multiple sedatives are available

Propofol and dexmedetomidine will liberate patients from mechanical ventilation faster than benzodiazepine therapy (even when administered intermittently) and are associated with less delirium

Use of benzodiazepines should be minimized

slide115

Conclusions

  • Cost of care calculations should consider the overall costs, not just drug acquisition costs
  • Early mobility in ICU patients decreases delirium and improves functional outcomes at discharge
  • Consider non-pharmacological management of delirium and reduce exposure to risk factors
  • Typical and atypical antipsychotic medications may be used to treat delirium if non-pharmacological interventions are not adequate