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

This study is not yet open for participant recruitment.
Verified January 2013 by VA Connecticut Healthcare System
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01769586
First received: January 14, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Sedation
Endoscopy
Drug: Diphenhydramine
Drug: Midazolam

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy

Resource links provided by NLM:


Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Proportion of patients who achieve adequate sedation to allow colonoscopy (defined as MOAA/S ≤3) [ Time Frame: Approximately 10 minutes or less ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diphenhydramine
Increments of 25 mcg to maximum of 3 times (total 75 mcg)
Drug: Diphenhydramine
Active Comparator: Midazolam
1.5 mg increments up to 3 times (maximum 4.5 mg)
Drug: Midazolam

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769586

Contacts
Contact: Loren Laine, MD 203-937-3462 loren.laine@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Not yet recruiting
West Haven, Connecticut, United States, 06516
Principal Investigator: Loren Laine, MD         
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Loren Laine, MD VA Connecticut Healthcare System
  More Information

No publications provided

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01769586     History of Changes
Other Study ID Numbers: 0003
Study First Received: January 14, 2013
Last Updated: January 14, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
Sedation
Endoscopy
Diphenhydramine
Midazolam

Additional relevant MeSH terms:
Diphenhydramine
Promethazine
Midazolam
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on April 23, 2014