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

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ClinicalTrials.gov Identifier: NCT01769586
Recruitment Status : Completed
First Posted : January 16, 2013
Results First Posted : September 30, 2016
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sedation Endoscopy Drug: Diphenhydramine Drug: Midazolam Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
Study Start Date : February 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : April 2016


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769586


Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Loren Laine, MD VA Connecticut Healthcare System

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01769586     History of Changes
Other Study ID Numbers: 0003
First Posted: January 16, 2013    Key Record Dates
Results First Posted: September 30, 2016
Last Update Posted: February 10, 2017
Last Verified: December 2016

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

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