Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis: A Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Intervention
- Ketamine/Propofol
- Conditions
- Conscious Sedation Failure During Procedure
- Sponsor
- Assiut University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Efficacy of ketofol in sedation
- Last Updated
- 4 years ago
Overview
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
Investigators
Haidi Karam
Associate professor
Assiut University
Eligibility Criteria
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.
Arms & Interventions
Ketofol group
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.
Intervention: Ketamine/Propofol
Propofol group
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.
Intervention: Propofol
Outcomes
Primary Outcomes
Efficacy of ketofol in sedation
Time Frame: 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 Outcomes
- Impact of ketofol on hemodynamics(24 hours)
- Impact of ketofol on oxygen saturation(24 hours)