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Clinical Trial Summary

Does Ketamine-Midazolam have a better efficacy and safety profile compared to Midazolam - Pethidine in Endoscopic Retrograde Cholangiopancreatography (ERCP)?


Clinical Trial Description

Ketamine- Midazolom is more efficacious in producing desired sedative state and have a better safety profile as a sedative agent in ERCP compared to Midazolam- Pethidine. The usage of sedative agent in ERCP depends on surgeon's preferences and availability of the drugs. The most commonly used sedatives in ERCP is Midazolam with pethidine. The use of Midazolam , however, is related to: 1. 20-45% failure of sedation during ERCP 2. Cardio-respiratory depression - apnoea: 15.4%, hypotension: 15.7%, bradycardia: 6.8% Due to the proven efficacy and safety profile of ketamine-midazolam as a sedative agent in procedural sedation, the investigators propose that the use of ketamine-midazolam as a sedative agent in ERCP is more effective and better safety profile when compared to Midazolam- Pethidine. The synergistic effect means to reduce the total dose of midazolam used. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06111872
Study type Interventional
Source National University of Malaysia
Contact Rajdave Singh
Phone +60102200836
Email rajdavee.s@gmail.com
Status Recruiting
Phase Phase 2
Start date July 18, 2023
Completion date June 30, 2024

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