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A Randomized, Double-Blinded, Placebo-Controlled Trial of Promethazine and Diphenhydramine as Adjunct Sedatives for Endoscopic Ultrasound (EUS) and Endoscopic Retrograde Cholangiopancreatography (ERCP)
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
H.H. Chao Comprehensive Digestive Disease Center
Orange, California, United States
Start Date
February 1, 2008
Primary Completion Date
June 1, 2012
Completion Date
June 1, 2012
Last Updated
February 26, 2024
304
ACTUAL participants
Meperidine, Midazolam
DRUG
Diphenhydramine
DRUG
Promethazine
DRUG
Lead Sponsor
University of California, Irvine
NCT07017283
NCT07263503
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