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NCT01769586 · ClinicalTrials.gov registry record · NA
Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy
A NA study, sponsored by VA Connecticut Healthcare System.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
NCT01769586: Completed NA study, sponsored by VA Connecticut Healthcare System.
NCT01769586 is a NA study that has completed, run by VA Connecticut Healthcare System. The registered enrollment target is 200 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769586, a NA study, has completed, sponsored by VA Connecticut Healthcare System.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Midazolam
- DRUG Diphenhydramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT01769586 record still lists
NCT01769586 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT01769586 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01769586 about?
NCT01769586 is a clinical study titled "Randomized Trial of Diphenhydramine Versus Continued Midazolam in "Difficult-to-sedate" Patients Undergoing Colonoscopy". 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 diphenhyd...
What is the current status of trial NCT01769586?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2013-02. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01769586?
The interventions under investigation include: Midazolam (DRUG), Diphenhydramine (DRUG).
Who is sponsoring clinical trial NCT01769586?
This trial is sponsored by VA Connecticut Healthcare System, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01769586's enrollment target sits among peer trials
200 506th of 2000 higher than 1,434 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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