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

Overview

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.

Full Title of Study: “Randomized Trial of Diphenhydramine Versus Continued Midazolam in “Difficult-to-sedate” Patients Undergoing Colonoscopy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2015

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.

Interventions

  • Drug: Diphenhydramine
  • Drug: Midazolam

Arms, Groups and Cohorts

  • Active Comparator: Diphenhydramine
    • Increments of 25 mcg to maximum of 3 times (total 75 mcg)
  • Active Comparator: Midazolam
    • 1.5 mg increments up to 3 times (maximum 4.5 mg)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Connecticut Healthcare System
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Loren Laine, MD, Principal Investigator, VA Connecticut Healthcare System

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