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

Information source: VA Connecticut Healthcare System
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sedation; Endoscopy

Intervention: Diphenhydramine (Drug); Midazolam (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: VA Connecticut Healthcare System

Official(s) and/or principal investigator(s):
Loren Laine, MD, Principal Investigator, Affiliation: VA Connecticut Healthcare System

Overall contact:
Loren Laine, MD, Phone: 203-937-3462, Email: loren.laine@yale.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Proportion of patients who achieve adequate sedation to allow colonoscopy (defined as MOAA/S ≤3)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Loren Laine, MD, Phone: 203-937-3462, Email: loren.laine@yale.edu

VA Connecticut Healthcare System, West Haven, Connecticut 06516, United States; Recruiting
Loren Laine, MD, Principal Investigator
Additional Information

Starting date: February 2013
Last updated: July 13, 2015

Page last updated: August 23, 2015

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