Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Assiut University

Status and phase: Unknown; Phase 4

Conditions: Conscious Sedation Failure During Procedure

Treatments: Drug: Ketamine/Propofol; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04997967

Ketofol in Urgent ERCP

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Ketofol group

Experimental group

Description:

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.

Treatment:

Drug: Ketamine/Propofol

Propofol group

Active Comparator group

Description:

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.

Treatment:

Drug: Propofol