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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
304
H.H. Chao Comprehensive Digestive Disease Center
Orange, California, United States
Average Percentage of Sedation Failures
The percentage of participants who could not complete the procedure due inability to achieve proper sedation level
Time frame: From onset of sedation to completion of procedure, approximately 1 hour.
Time to Achieve Adequate Level of Sedation to Begin Procedure
Time frame: Pre-Endoscopic Procedure (up to 1 hour maximum)
Time for Recovery
Time frame: Post-Endoscopic Procedure
Adverse Symptoms From Sedative Agents
Time frame: Approximately 3 hours.
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