Trials / Completed
CompletedNCT00937924
Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures
A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine as Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 304 (actual)
- Sponsor
- University of California, Irvine · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare meperidine/midazolam with diphenhydramine, meperidine/midazolam with promethazine, and meperidine/midazolam with placebo as sedation methods. The investigators are interested to see whether adjunct sedatives (diphenhydramine and promethazine) will improve sedation.
Detailed description
Comparing sedation techniques during invasive endoscopic procedures such as ERCP and EUS is a relatively unexplored area of clinical research. In particular, the effectiveness of adjunct sedatives such as diphenhydramine and promethazine during ERCP/EUS procedures has not been studied. Achieving a moderate sedation level may be ideal for ERCP/EUS procedures in order to provide adequate patient comfort, amnesia, and completion of intended endoscopic procedures. The relevance of further studies in this area is apparent. In terms of clinical practice; over-sedation can lead to decreased airway protection, longer post-procedural recovery times, and unnecessary drug cost; under-sedation can lead to patient anxiety, agitation, recall, and longer procedural time.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Meperidine, Midazolam | |
| DRUG | Diphenhydramine | |
| DRUG | Promethazine |
Timeline
- Start date
- 2008-02-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2009-07-13
- Last updated
- 2024-02-26
- Results posted
- 2024-02-26
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00937924. Inclusion in this directory is not an endorsement.