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Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Conscious Sedation Failure During Procedure Clinical Trial

Official title:
Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial

Clinical Trial Summary

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a lengthy and uncomfortable procedure that requires adequate sedation. Propofol is the commonly used sedative during ERCP. However, dose dependent cardiac and respiratory depression may occur. Hypotension usually occurs in severe cholangitis which necessitate the use of alternative sedative. The aim is to study the efficacy and safety of ketofol as a sedative during urgent ERCP for severe cholangitis.

Clinical Trial Description

This randomized controlled trial was carried out on 96 patients undergoing urgent ERCP for severe cholangitis. Patients were allocated into two groups; group 1: received ketofol and group 2: received propofol. Demographic data, ERCP duration, recovery time, heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation, Ramsey Sedation Scale (RSS), pain Numerical Rating Scale (NRS), propofol requirement, adverse events, endoscopists and patients satisfaction were recorded ;

Study Design

Related Conditions & MeSH terms

  • Cholangitis
  • Conscious Sedation Failure During Procedure
Clinical Trial Details
NCT number NCT04997967
Study type Interventional
Source Assiut University
Contact Haidi Ramadan, Phd
Phone +201028186710
Email haidikaram@aun.edu.eg
Status Recruiting
Phase Phase 4
Start date July 1, 2020
Completion date August 2021
View Details
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