1 / 20

Dexmedetomidine for Sedation During Elective Awake Fiberoptic Intubation: A Multicenter Trial

Dexmedetomidine for Sedation During Elective Awake Fiberoptic Intubation: A Multicenter Trial.

marty
Download Presentation

Dexmedetomidine for Sedation During Elective Awake Fiberoptic Intubation: A Multicenter Trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Dexmedetomidine for Sedation During Elective Awake FiberopticIntubation: A Multicenter Trial Sergio D Bergese, Keith Candiotti, Andrew Zura, Paula M Bokeschand Alex Y BekkerPresented at the American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  2. Background • An awake fiberoptic intubation (AFOI) is indicated for patients with an anticipated difficult airway due to their anatomy, airway trauma, morbid obesity, or unstable cervical spine injuries • Benzodiazepines, combined with opioids, are commonly used during AFOI • However, these agents can cause respiratory depression, in addition to the desired sedation, increasing the risk for hypoxemia and aspiration • There is an unmet need for a primary sedative that provides adequate sedation during AFOI while maintaining a patent airway and patient responsiveness Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  3. Background • A number of case reports and retrospective studies have demonstrated the success of using dexmedetomidine (DEX) for AFOI • However, there has not been a prospective, doubleblind, multicenter clinical trial in this population to date • This phase III multicenter study evaluated the safety and efficacy of DEX compared with placebo (PBO) in the sedation of nonintubated patients with anticipated difficult to intubate airways who were undergoing AFOI prior to a surgical or diagnostic procedure Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  4. Purpose • This phase III multicenter study evaluated the safety and efficacy of DEX compared with placebo (PBO) in the sedation of nonintubated patients with anticipated difficult to intubate airways who were undergoing AFOI prior to a surgical or diagnostic procedure Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  5. Methods • A phase III, randomized, double-blind placebo-controlled study was conducted at 17 US sites with institutional approval and informed written patient consent • Patients ≥ 18 years old scheduled for an elective AFOI due to an anticipated difficult airway and who had an American Society of Anesthesiologists physical status classification score of I-IV were included Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  6. Methods • Patients received DEX 1 mcg/kg loading dose over 10 min followed by a 0.7 mcg/kg/hr maintenance infusion or PBO with an equal loading and maintenance dose of normal saline • After topical anesthesia (lidocaine) and a Ramsay Sedation Scale (RSS) score ≥ 2 was achieved, nasal or oral intubation using a flexible fiberoptic bronchoscope was performed • Following successful intubation, the drug infusion was discontinued, general anesthesia was induced, and scheduled procedure proceeded • Midazolam (MDZ) was administered at any time as rescue medication at increments of 0.5 mg up to 0.2 mg/kg for patients with a RSS score of 1 until target RSS score of ≥ 2 Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  7. Methods • All patients’ vital signs were continuously monitored and baseline RSS scores were documented • The primary endpoint was the percentage of patients requiring rescue midazolam (MDZ) to achieve and/or maintain a target sedation level (Ramsay Sedation Scale [RSS] score ≥ 2) throughout the infusion • Secondary endpoints included anesthesiologists’ and patients’ satisfaction assessments • Immediately following the procedure, anesthesiologists responded to questions about the intubation using a Visual Analog Scale • At the end of the 24-hour follow up, patients were assessed for AFOI satisfaction (recall of intubation, discomfort, and satisfaction) • All statistical analyses were 2-sided, and P values ≤ 0.05 were considered significant Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  8. Methods • Safety was assessed by adverse events, protocol prespecified laboratory tests, vital signs, cardiac monitoring and concomitant medications • Hemodynamic stability was evaluated using a composite endpoint of the time a patient’s systolic blood pressure (SBP) and/or heart rate (HR) was outside of the hemodynamically stable range • A score = 2 means both SBP and HR were outside of the stable range, while a score = 0 means neither SBP nor HR were outside of the stable range at anytime during the infusion Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  9. Methods • Major exclusions: • Use of an a-2 agonist or antagonist within 14 days of study entry • Use of an opioid administered orally or intravenously within 1 hour or intramuscularly within 4 hours of study drug administration • Presence of central nervous system disease with an anticipated increased intracranial pressure or cerebrospinal fluid leak or acute alcoholic intoxication • Uncontrolled seizure disorder and/or psychiatric illness • History of acute unstable angina • Laboratory-confirmed acute myocardial infarction within the past 6 weeks • Heart rate < 50 beats per minute • Systolic blood pressure (SBP) < 90 mm Hg • Complete heart block unless the patient had a pacemaker Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  10. Results • A total of 105 patients (DEX = 55; PBO = 50) were included in the intent-to-treat and safety analyses • Of the 55 patients in the DEX group, 49 (89.1%) completed the study drug infusion and were intubated; of the 50 patients in the PBO group, 46 (92%) completed study drug infusion and were intubated • No demographic differences were noted between groups Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  11. Methods: Patient Demographics and Baseline Characteristics of Interest Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  12. Results • Significantly fewer patients in the DEX group required rescue MDZ to achieve and/or maintain sedation compared with the PBO group • 47.3% vs. 86.0%, P < 0.001 • The total mean supplemental MDZ dose required was significantly lower in DEX-treated patients than in PBO-treated patients • 1.07 mg v. 2.85 mg, P < 0.001 Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  13. Results: Rescue Midazolam (MDZ) Administration and Dose Did Not Require MDZ Required MDZ 100 14% 90 53% 80 86% 70 60 Patients (%) 50 40 47%* 30 20 Mean MDZDose1.07 mg* Mean MDZDose1.07 mg* 10 0 Placebo (n=50) Dexmedetomidine(n=55) *P<0.001 vs. placebo.BergeseS.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  14. Results • No patients in the DEX group required additional medication other than MDZ to achieve targeted RSS • Four PBO patients required supplemental fentanyl or propofolto maintain RSS ≥ 2 • Among patients with the most difficult airways, Mallampati classification IV, significantly more patients in the PBO group required rescue MDZ than in the DEX group • Mean RSS scores assessed 15 minutes after starting study drug infusion were significantly higher with DEX versus PBO Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  15. Results • Hemodynamic changes after study drug infusion were similar in pattern to those during study drug infusion • Hemodynamic stability composite endpoints were similar between the DEX-treated and the PBO-treated groups (0.12 and 0.14, respectively; P = 0.671) • Seven DEX-treated patients (12.7%) and 4 PBO-treated patients (8.0%) received medication to treat blood pressure • the difference was not clinically or statistically significance (P = 0.5316) Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  16. Results: Mean Hemodynamic Changes Versus Baseline During Study Drug Infusion Period *P < 0.001 for change from baseline vs placebo (based on one-way analysis of variance). †P = 0.034 for change from baseline vs placebo (based on one-way analysis of variance).BergeseS.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  17. Results • No significant differences were noted in the percentage of adverse events experienced by the 2 groups • Treatment-related adverse events were reported by 29.1% and 18% of DEX and PBO patients, respectively (P = 0.252) • The percentage of patients in the DEX group (16.4%) experiencing protocol-defined respiratory depression was similar to the PBO-treated group (14.0%) • Cardiovascular adverse events: • DEX was well tolerated in patients also receiving a betablocker with only one patient experiencing protocol-defined bradycardia Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  18. Results: Cardiovascular Adverse Events During Study Drug Infusion Protocol-defined hypotension: SBP < 80 mm Hg, DBP < 50 mm Hg, or SBP decreased ≤ 30% below baseline values. Protocol-defined hypertension: SBP > 180 mm Hg, DBP > 100 mm Hg, or SBP increased ≥ 30% higher than baseline values. Protocol-defined tachycardia: HR > 120 bpm or increased ≥ 30% higher than baseline values. Protocol-defined bradycardia: HR < 40 bpm or decreased ≤ 30% below baseline values. *P values derived from Fisher exact test.Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  19. Results • The anesthesiologists rated both groups similarly in ease of intubation, hemodynamic stability, and patient cooperation • The majority of patients in both groups did not recall feeling anxiety or pain during the AFOI and were highly satisfied with the procedure • 47.1% of DEX patients and 53.2% of PBO patients did not feel anxious • 64.7% of DEX patients and 61.7% of PBO patients did not feel pain Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

  20. Discussion • DEX was efficacious as a primary sedative in patients with high-risk airways undergoing AFOI • DEX was well tolerated and attenuated the stress response without airway compromise in this high-risk population • There was significantly less hypertension and tachycardia with Dexvs placebo (86% received midazolam) Bergese S.D., et. al. American Society of Anesthesiologists (ASA) 2008 Annual Meeting. October 18–22, 2008, Orlando, FL.

More Related