Ketofol Versus Propofol in Urgent ERCP for Acute Cholangitis

Ketamine

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.

Intervention / Treatment

  • Ketamine/Propofol (DRUG)
    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.
  • Propofol (DRUG)
    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.

Condition or Disease

  • Conscious Sedation Failure During Procedure

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Enrollment: 100 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Health Services Research

    Masking

    Clinical Trial Dates

    Start date: Jul 01, 2020 ACTUAL
    Primary Completion: Aug 01, 2021 ESTIMATED
    Completion Date: Aug 01, 2021 ESTIMATED
    Study First Posted: Aug 10, 2021 ACTUAL
    Last Updated: Aug 06, 2021

    Sponsors / Collaborators

    Lead Sponsor: Assiut University
    Responsible Party: N/A

    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

    Participant Groups

    • 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.

    • 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.

    Eligibility Criteria

    Sex: All
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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

    • Heart rate (beats/min)

    • Pulse oximeter (SO2)

    • Blood pressure(mmHg)

    More Details

    NCT Number: NCT04997967
    Other IDs: Ketofol in Urgent ERCP
    Study URL: https://clinicaltrials.gov/study/NCT04997967
    Last updated: Sep 29, 2023