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

Not Applicable

Completed

• Conditions: Sedation; Endoscopy
• Interventions: Drug: Diphenhydramine; Drug: Midazolam

• Registration Number: NCT01769586
• Lead Sponsor: VA Connecticut Healthcare System

Brief 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.

Detailed Description

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 (up to 3 incremental doses of 25 mcg each) vs. continued midazolam (up to 3 incremental doses of 1.5 mg each). the level of sedation will be assessed using the MOAA/S scale 2-3 minutes after each administration to determine if they are sufficiently sedated to begin colonoscopy. The patient, the healthcare team involved in performing the endoscopy, and the investigator assessing sedation will be blinded to the therapy. 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.

Study Timeline

• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Study Start: 2013-02
• Primary Completion: 2015-06
• Study Completion: 2016-04
• Results First Submitted: 2016-07-11
• Results First Submitted QC: 2016-08-05
• Results First Posted: 2016-09-30
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-19
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diphenhydramine	Diphenhydramine	Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Midazolam	Midazolam	1.5 mg increments up to 3 times (maximum 4.5 mg)

Primary Outcome Measures

Name	Time	Method
Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)	Approximately 10 minutes or less	Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. This scale ranges from 0 to 5, where 0 denotes general anesthesia, in which the patient has no response to painful stimuli, and 5 denotes a level of minimal sedation in which the patient is fully awake.

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States