drugset / Trial / NCT01769586

Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy

NCT01769586

Completed 200 enrolled VA Connecticut Healthcare System
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Patients who are undergoing colonoscopy and are not adequately sedated after initial standard sedation with midazolam 5 mg and fentanyl 100 mcg will be randomly assigned to receive diphenhydramine vs. continued midazolam, and their level of sedation will be assessed. Our hypothesis is that diphenhydramine will provide better sedation than continued administration of midazolam during colonoscopy in patients not achieving adequate sedation with standard doses of midazolam plus fentanyl.

Timeline

Start
2013-02
Primary completion
2015-06
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Diphenhydramine Unknown 25 ug
Comparator Midazolam Small molecule 1.5 mg

Indications

No indication recorded.