Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Phase 4

• Conditions: Conscious Sedation Failure During Procedure
• Interventions: Drug: Ketamine/Propofol; Drug: Propofol

• Registration Number: NCT04997967
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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 Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2021-07-11
• Status Verified: 2021-08
• Primary Completion: 2021-08
• Study Completion: 2021-08
• Study First Submitted QC: 2021-08-06
• Last Update Submitted: 2021-08-06
• Study First Posted: 2021-08-10
• Last Update Posted: 2021-08-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Severe acute cholangitis of either sex
• Aged between 21-70 years
• Undergoing urgent therapeutic ERCP for severe cholangitis with American Society of Anaesthesiologist (ASA) Grade II - III.

Exclusion Criteria

• Patients who had ASA physical status Grade VI,
• Baseline SpO2 <90%,
• Patients who had difficulty in communication,
• Patients allergic to the studied medications,
• Morbidly obese patients,
• Patients with chronic obstructive pulmonary disease,
• Complicated airway,
• Pregnant patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketofol group	Ketamine/Propofol	Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Will receive Ketofol (ketamine: propofol concentration 1:4) prepared in 50 ml syringe containing dextrose 5% (each ml contained 8 mg propofol and 2 mg ketamine), administered as following; 5 ml of ketofol as loading then infusion titrated till targeted RSS score.
Propofol group	Propofol	Patients undergoing urgent therapeutic ERCP for severe cholangitis, with American Society of Anaesthesiologist (ASA) Grade II - III. Sedation was initially started by bolus dose of 0.5 mg/kg propofol IV over 3 minutes then, infusion was started at the rate of 50 µg /kg/min till RSS score of 5.

Primary Outcome Measures

Name	Time	Method
Efficacy of ketofol in sedation	24 hours	The time to reach Ramsay Sedation Scale score of 5 to ensure adequate sedation. This scale is between 1-6.; The score 5 and 6 indicates adequate sedation while score \<5 indicates inadequate sedation.

Secondary Outcome Measures

Name	Time	Method
Impact of ketofol on oxygen saturation	24 hours	Pulse oximeter (SO2)
Impact of ketofol on hemodynamics	24 hours	Blood pressure(mmHg)

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt