Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | December 2016 |
| Contact: | Loren Laine, MD |
| Email: | loren.laine@yale.edu |
| Phone: | 203-937-3462 |
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.
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.
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.
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.
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
We found this trial at
1
site
950 Campbell Ave
West Haven, Connecticut 06516
West Haven, Connecticut 06516
(203) 932-5711
Principal Investigator: Loren Laine, MD
VA Connecticut Healthcare System VA Connecticut encompasses an inpatient facility and Ambulatory Care Center in...
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