A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation for Elective Awake Fiberoptic Intubation

Phase 3 Completed 124 enrolled Pfizer

RandomizedSingle-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.

Timeline

Start: 2006-08
Primary completion: 2007-01
Completion: 2007-03

Outcome

Met primary endpoint

paper Less rescue midazolam was required to maintain Ramsay Sedation Scale ≥2 (47.3% vs. 86.0%, P < 0.001) PMID 20535016 ↗

Publications

Bergese SD, Candiotti KA, Bokesch PM, Zura A, Wisemandle W, Bekker AY; AWAKE Study Group. A Phase IIIb, randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of dexmedetomidine for sedation during awake fiberoptic intubation. Am J Ther. 2010 Nov-Dec;17(6):586-95. doi: 10.1097/MJT.0b013e3181d69072.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	0.7 ug/kg	—

Indications

No indication recorded.