Phase 4
Completed N=304
Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures
Endoscopic Ultrasound (EUS) · Endoscopic Retrograde Cholangiopancreatography (ERCP)
Source: ClinicalTrials.gov NCT00937924 ↗
Enrolled (actual)
304
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcomePrimary: Average Percentage of Sedation Failures — 14; 13; 5 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Percentage of Sedation Failures |
14; 13; 5 | — |
| PRIMARY Time to Achieve Adequate Level of Sedation to Begin Procedure |
15; 13; 14 | — |
| PRIMARY Time for Recovery |
21.3; 29.5; 51.5 | — |
| SECONDARY Adverse Symptoms From Sedative Agents |
0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.
Exclusion Criteria
- History of allergic or adverse reactions to midazolam, diphenhydramine, or promethazine.
- Acute asthma, narrow angle glaucoma, concurrent use of potent inhibitors of CYP3A4 (amprenavir, atazanavir, or ritonavir), pregnancy, or the inability to consent.
- Patients with conditions that preclude safe conscious sedation will be excluded.
Data sourced from ClinicalTrials.gov (NCT00937924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.