Sedation Regimens in GI Endoscopy
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- STATUS
- Recruiting
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- End date
- Dec 6, 2023
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- participants needed
- 772
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- sponsor
- Greg S Cohen MD LLC
Summary
This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. English-speaking patients 18 years old and 75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) [Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.
Details
| Condition | Anesthesia (Local), dental anesthesia, Endoscopy, anaesthesia, Anesthesia, moderate sedation, anesthesia procedures, endoscopic procedure, Conscious Sedation, sensory loss, endoscopic examination, colonoscopy, anesthesia for |
|---|---|
| Treatment | midazolam alone |
| Clinical Study Identifier | NCT04807101 |
| Sponsor | Greg S Cohen MD LLC |
| Last Modified on | 6 August 2021 |
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