Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 16, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
September 30, 2016
CompletedFebruary 10, 2017
December 1, 2016
2.3 years
January 14, 2013
July 11, 2016
December 19, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Who Achieve Adequate Sedation to Allow Colonoscopy (Defined as MOAA/S ≤3)
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.
Approximately 10 minutes or less
Study Arms (2)
Diphenhydramine
ACTIVE COMPARATORIncrements of 25 mcg to maximum of 3 times (total 75 mcg)
Midazolam
ACTIVE COMPARATOR1.5 mg increments up to 3 times (maximum 4.5 mg)
Interventions
Eligibility Criteria
You may qualify if:
- Patients \>18 years-old who are undergoing elective colonoscopy with conscious sedation
You may not qualify if:
- allergy or prior adverse reactions to diphenhydramine
- medical contraindications to use of diphenhydramine (e.g. closed angle glaucoma)
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Related Publications (1)
Sachar H, Pichetshote N, Nandigam K, Vaidya K, Laine L. Continued midazolam versus diphenhydramine in difficult-to-sedate patients: a randomized double-blind trial. Gastrointest Endosc. 2018 May;87(5):1297-1303. doi: 10.1016/j.gie.2017.01.028. Epub 2017 Jan 31.
PMID: 28159539DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Loren Laine
- Organization
- VA Connecticut Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Loren Laine, MD
VA Connecticut Healthcare System
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 16, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2015
Study Completion
April 1, 2016
Last Updated
February 10, 2017
Results First Posted
September 30, 2016
Record last verified: 2016-12