Dexmedetomidine Versus Midazolam for Facilitating Extubation

Completed 23 enrolled University of Colorado, Denver Hospira, now a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this randomized, double-blind study is to evaluate the utility, safety, and cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing. Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine therapy and qualifying for daily awakenings will be randomized in a double-blind manner to receive additional midazolam or dexmedetomidine.

Timeline

Start: 2008-08
Primary completion: 2012-10
Completion: 2012-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Midazolam vs Dexmedetomidine; p = 0.8; Wilcoxon (Mann-Whitney) NCT00744380 ↗

Publications

MacLaren R, Preslaski CR, Mueller SW, Kiser TH, Fish DN, Lavelle JC, Malkoski SP. A randomized, double-blind pilot study of dexmedetomidine versus midazolam for intensive care unit sedation: patient recall of their experiences and short-term psychological outcomes. J Intensive Care Med. 2015 Mar;30(3):167-75. doi: 10.1177/0885066613510874. Epub 2013 Nov 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	0.15 ug/kg	—
Comparator	Midazolam	Small molecule	1 mg	—

Indications

No indication recorded.