Status:
COMPLETED
Adjunct Sedatives in Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP) Procedures
Lead Sponsor:
University of California, Irvine
Conditions:
Endoscopic Ultrasound (EUS)
Endoscopic Retrograde Cholangiopancreatography (ERCP)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 ...
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 suc...
Eligibility Criteria
Inclusion
- Willing participants between 18 and 75 years of age who present for ERCP or EUS at H.H. Comprehensive Chao Digestive Disease Center.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT00937924
Start Date
February 1 2008
End Date
June 1 2012
Last Update
February 26 2024
Active Locations (1)
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1
H.H. Chao Comprehensive Digestive Disease Center
Orange, California, United States, 92868