NCT06111872

Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography.

Combination Use of Intravenous Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography ; A Randomized Control Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cholangitis
• Pancreatic Cancer
• Choledocholithiasis
• Choledochal Cyst

Interventions

Type	Name	Description
DRUG	Ketamine	Administration described in arm/ group description
DRUG	Midazolam	Administration described in arm/ group description
DRUG	Pethidin	Administration described in arm/ group description

Timeline

• Start date: 2023-07-18
• Primary completion: 2024-02-27
• Completion: 2024-10-25
• First posted: 2023-11-01
• Last updated: 2025-03-25

Locations

1 site across 1 country: Malaysia