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Dexmedetomidine for Monitored Anesthesia Care (MAC). Alex Y. Bekker, MD, PhD Associate Professor of Anesthesiology and Neurosurgery New York University Medical Center New York, New York.

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slide1

Dexmedetomidine for Monitored

Anesthesia Care (MAC)

Alex Y. Bekker, MD, PhD

Associate Professor of Anesthesiology

and Neurosurgery

New York University Medical Center

New York, New York

slide2

“We have completed our review of this application, as amended, and it is approved, effective on the date of this letter, for use as recommended in the enclosed agreed-upon labeling text.”

monitored anesthesia care definition
Monitored Anesthesia Care: Definition

Monitored Anesthesia Care (MAC) may include varying levels of sedation, analgesia, and anxiolysis as necessary. The provider of MAC must be prepared and qualified to convert to general anesthesia when necessary.

Position on Monitored Anesthesia Care, ASA 2005

continuum of depth of sedation
Continuum of Depth of Sedation

Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists, Anesthesiology 2002

injury and liability associated with monitored anesthesia care

*

*

*

% of claims in anesthesia group

*

* P<.025 MAC versus Regional

Injury and Liability Associated with Monitored Anesthesia Care
  • Bhananker and colleagues assessed the patterns of injury and liability associated with monitored anesthesia care (MAC; n = 121) as compared with general (n = 1519) and regional anesthesia (n = 312)

Bhananker S, Anesthesiology 2006

injury associated with mac
Injury Associated with MAC

N=121 %

Respiratory event 24

Cardiovascular event 14

Equipment failure/malfunctioning 21

Related to regional block 2

Inadequate anesthesia/patient movement 11

Medication related 9

Other events 20

Bhananker S, Anesthesiology 2006

characteristics of an ideal sedative
Characteristics of an Ideal Sedative
  • Cooperative sedation
  • Minimal depression of ventilation
  • Hemodynamic stability
  • Analgesic effects
  • Wide therapeutic window
  • Minimal risks of side effects
  • Favorable pharmacodynamic/ pharmacokinetic profile
  • Amnesia (?)
study design monitored anesthesia care
Study Design: Monitored Anesthesia Care

325 Patients: 260 Dex; 65 Placebo receiving MAC for surgical procedures; 25 US sites

2 Precedex Arms: 0.5 mcg/kg/10 min load or 1.0 mcg/kg/10 min load; 0.6 mcg/kg/hr maintenance titrated 0.2 – 1.0 mcg/kg/hr.

OAA/S Scale: Midazolam rescue for > 4.

Primary Endpoint: % of pts not requiring MDZ based on OAA/S.

Secondary Endpoints: total MDZ, fentanyl, sedation failures; pt satisfaction; anesthesiologist assessment; PONV

Safety: respiratory depression; hemodynamic stability

overview of awake fiberoptic intubation trial
Overview of Awake Fiberoptic Intubation Trial
  • Double-blind, randomized, placebo-controlled
  • 100 patients: 50 Precedex; 50 Placebo; 18 US sites
  • Precedex: 1.0 mcg/kg/10 min; 0.7 mcg/kg/hr maint
  • Rescue is Midazolam(0.5 mg doses) based on Ramsay Sedation Scale of 1.
  • Primary Endpoint: % of patients requiring Midazolam
  • Secondary Endpoints: Total MDZ dose; other rescue meds; patient satisfaction; anesthesiologist assessment
  • Safety Endpoints: hemodynamic stability; respiratory depression
characteristics of cooperative sedation
In cooperative sedation, patients easily transition from sleep to wakefulness and task performance when aroused

Patients are able to resume rest when not stimulated

Cooperative sedation is most useful during procedures in which communication with the patient must be maintained

Facilitates participation in therapeutic maneuvers

Allows for patient interaction in care decisions

May contribute to shorter recovery room convalescence

Reduces risk of developing drug-induced complications

Characteristics of Cooperative Sedation
the brain is not a sausage it s more like a well tuned musical instrument rudolfo llinas
“The brain is not a sausage, it’s more like a well tuned musical instrument” Rudolfo Llinas

Endogenous sleep

Loss of response to external stimuli

Sedative component of anesthesia

arousability from sedation during dexmedetomidine infusion
Arousability From Sedation During Dexmedetomidine Infusion
  • Patients were infused with placebo or 1 of 2 doses of dexmedetomidine and monitored with the Bispectral Index System (BIS) before stimulation and immediately after being asked to perform cognitive and cold pressor tests
  • Patients receiving either infusion of dexmedetomidine could be completely aroused by a mild stimulus1

Just prior to cognitive and cold pressor testing

During cognitive and cold pressor testing

Dexmedetomidine Infusion

(mcg/kg/h)

BIS indicates Bispectral Index System

Hall JE, Anesth Analg 2000

dexmedetomidine in carotid endarterectomy
Dexmedetomidine in Carotid Endarterectomy
  • Avoid oversedation
  • Reduce anxiety
  • Maintain communication
  • Minimize respiratory depression
intraoperative assessment of sedation level by the blinded observer
Intraoperative Assessment of Sedation Level by the Blinded Observer

Bekker A , J Neurosurg Anesth 2004

the safety of dexmedetomidine as primary sedative for awake cea
The Safety of Dexmedetomidine as Primary Sedative for Awake CEA

Total number of patients

N=151

General Anesthesia

N=10

Regional/Dex

N=123

Regional/No Dex

N=18

No Shunt

N=0

Shunt

N=10

No Shunt

N=111

Shunt

N=12

No Shunt

N=12

Shunt

N=6

Elective

N=10

Obligatory

N=0

Elective

N=7

Obligatory

N=5

Elective

N=4

Obligatory

N=2

Bekker A, Anesth Analg 2006

clinical experience with dexmedetomidine for dbs implantation
Clinical Experience with Dexmedetomidine for DBS Implantation
  • Dex (0.3-0.6 mcg/kg/hr) did not impair intensity of movement disorder or interfere with MER in PD patients
  • Titration of Dex provided satisfactory sedation for DBS implantation
  • Dex provided HD stability and decreased the use of antihypertensives1
  • Propofol induced dyskinesia was controlled with DEX during DBS placement2

1Rozet I, Anesth Analg 2006. 2 Deogaonkar A , Anesthesiology 2006.

dexmedetomidine and respiratory depression
Dexmedetomidine and Respiratory Depression
  • Minimal effects on ventilation is well documented in human volunteers 1
  • Lack of respiratory depression was demonstrated in ICU patients 2

1Belleville JP, Anesthesiology, 1992; Ebert TJ, Anesthesiology, 2000. 2 Venn RM, Crit Care , 2000; Martin E, J Intensive Care Med 2004.

hospira mac trial respiratory depression
Hospira MAC Trial: Respiratory Depression

Definition of Respiratory Depression:

Respiratory rate < 8 bpm or oxygen saturation < 90%

Dex 0.5 Dex 1.0 Pcb

5 (3.7%) 3 (2.3%) 8 (12.7%) P<0.018

Both Dex groups: neither respiratory depression nor intervention

Plb group: respiratory depression or a need for intervention 13.1% and 16.1% respectively

dexmedetomidine and hemodynamic stability
Dexmedetomidine and Hemodynamic Stability

Arain SR, Anesth Analg 2002

Bekker A, J NeurosurgAnesth2004

postoperative effects of dexmedetomidine
Postoperative Effects of Dexmedetomidine

100

Propofol

Dexmedetomidine

40

30

Improved postoperative pain and greater sedation with dexmedetomidine compared with propofol

VAS Pain

Less Pain More Pain

20

* †

10

0

100

* †

80

Less Alert More Alert

VAS Sedation

60

40

0

Pre-

surg

5

35

50

65

Surg

End

20

Time After Surgery, minutes

*P<.05 difference over time compared with baseline

†P<.05 difference between groups

  • Arain SR, Anesth Analg, 2002
morphine sparing effects in inpatient surgery

Morphine

Dexmedetomidine

P<.01

Morphine-Sparing Effects in Inpatient Surgery
  • 34 patients scheduled for inpatient surgery
  • Randomized to either dexmedetomidine or morphine
  • Agents were started 30 minutes before the end of surgery
  • Dexmedetomidine reduced the early postoperative need for morphine by 66%

P<.01

  • Arain SR, Anesth Analg 2004
dexmedetomodine was tried as a primary sedative for
Dexmedetomodine Was Tried as a Primary Sedative for:
  • Sedation in CT and MRI imaging studies

Mason K, Ped Anesth 2008

Koroglu A, Anesth Analg 2006

  • Outpatient third molar surgery

Ustin Y, J Oral Maxilfac Surg 2006

Cheung C, Anaesthesia 2007

  • Cataract surgery

Alhashemi J, Br J Anaest 2006

  • Cardiac catheterization

Tosun Z, J Card Vasc Anesth 2006

Mester R, Am J Therap 2008

use of dexmedetomidine in mri
Use of Dexmedetomidine in MRI
  • 80 children aged 1-7 years
  • Randomly assigned to either dexmedetomidine or midazolam
    • 10-minute loading doses: 1 mcg/kg dexmedetomidine, 0.2 mg/kg midazolam
    • Infusions: 0.5 mcg/kg/h dexmedetomidine, 6 mcg/kg/h midazolam1
  • The quality of MRI was significantly better (P<.001) and the rate of adequate sedation was significantly higher (P<.001) with dexmedetomidine

Quality of MRI

*

1 = no motion

2 = minor movement

3 = major movement necessitating another scan

*

*P<.001 compared with midazolam

  • Koroglu A, Br J Anaesth 2005
dexmedetomidine for gi procedures
Dexmedetomidine for GI Procedures

Jalowiecki P, Anesthesiology 2005

Use of Dex was associated with bradycardia, hypotension, vertigo, nausea/vomiting, prolonged recovery

Muller R, Gastroint Endosc 2008

Clinical efficacy of Dex alone is less than propofol during ERCP

Demiraran Y, Can J Gastroenter 2007

Dex may be a good alternative to midazolam for upper endoscopy

dexmedetomidine safety
Dexmedetomidine: Safety

Propofol

TI = 3.5

Harrison N, Anesthetic Pharmacology, 2004

Dexmedetomidine:

Jorden V, Ann Pharmacoth, 2004

Pt 1 - 60 times the prescribed dose

Pt 2 - 10 times the prescribed dose

Pt 3 - 60 times the prescribed dose

Ramsay M, Anesthesiology, 2004

Pt 1 - Infusion rate 10 mcg/kg/h

Pt 2 - Infusion rate 5 mcg/kg/h

Pt 3 – Infision rate 5 mcg/kg/h

Therapeutic Index = (median lethal dose [LD50] / (mean effective dose [ED50]

slide35

All progress is based upon a universal innate

desire on the part of every organism to live

beyond its income