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

Completed · Not applicable

Conditions studied: Sedation, Endoscopy

In brief

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.

Key facts

Study ID

NCT01769586

Run by

VA Connecticut Healthcare System

People needed

200

Starts

2013-02-01

Expected to finish

2016-04-01

Last updated by the study team

2017-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients >18 years-old who are undergoing elective colonoscopy with conscious sedation

You may not qualify if…

• allergy or prior adverse reactions to diphenhydramine
• medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma)
• pregnancy

Where it is running

• VA Connecticut Healthcare System — West Haven, Connecticut, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.