Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Conscious Sedation Failure During Procedure
• Intervention / Treatment: Drug: Ketamine/Propofol; Drug: Propofol

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Haidi Ramadan, Phd; Phone Number: +201028186710; Email: haidikaram@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Recruiting
    • Assiut University
    • Contact: Haidi Ramadan, rofessor; Phone Number: +0201028186710; Email: haidikaram@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ketamine/Propofol; The level of sedation was assessed at 1-3 min intervals, and the infusion rate was adjusted accordingly to achieve a Ramsay Sedation Scale (RSS) score of 5. Any movement of the patient was treated by increasing infusion rate and the infusion was discontinued at the end of the procedure. The total propofol consumed was calculated and the recovery time was recorded and calculated as the time from discontinuation of infusion of the study drug till achievement of RSS score of 3. Then patients were discharged to post-anesthesia care unit (PACU) after attaining an Aldrete Recovery Scale Score of 9- 10 [19]. Time taken to achieve this score was also recorded.
Active Comparator: 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.	Drug: Propofol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of ketofol in sedation	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.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of ketofol on hemodynamics	Heart rate (beats/min)	24 hours
Impact of ketofol on oxygen saturation	Pulse oximeter (SO2)	24 hours
Impact of ketofol on hemodynamics	Blood pressure(mmHg)	24 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Haidi Ramadan, PhD, Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 11, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Hypnotics and Sedatives; Ketamine; Propofol
• Other Study ID Numbers: Ketofol in Urgent ERCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Direct contact with the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No