A Safety and Efficacy Study of Dexmedetomidine in ICU Patients Requiring Continuous Sedation

Phase 4 Completed 420 enrolled Pfizer

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine in ICU subjects who are initially intubated, mechanically ventilated and require sedation for beyond 24 hours.

Timeline

Start: 2005-03
Primary completion: —
Completion: 2007-08

Outcome

Missed primary endpoint

paper There was no difference in percentage of time within the target RASS range PMID 19188334 ↗

paper difference, 2.2% [95% confidence interval {CI}, -3.2% to 7.5%]; P = .18 PMID 19188334 ↗

Publications

Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG; SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA. 2009 Feb 4;301(5):489-99. doi: 10.1001/jama.2009.56. Epub 2009 Feb 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	—	—
Comparator	Midazolam	Small molecule	—	Intravenous

Indications

No indication recorded.