Comparison of Different Ratio of Ketofol (6:1 vs. 4:1) for Sedation in Endoscopic Retrograde Cholangiopancreatography (ERCP)

Ketamine

Brief Summary

Study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

Intervention / Treatment

  • Propofol and Ketamine Mixture (Ketofol) (DRUG)
    Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1

Condition or Disease

  • Analgesia

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 58 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    SINGLE:
    • Participant

    Clinical Trial Dates

    Start date: Mar 01, 2017 ACTUAL
    Primary Completion: May 01, 2017 ACTUAL
    Completion Date: Jun 01, 2017 ACTUAL
    Study First Posted: Jul 23, 2019 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 22, 2019

    Sponsors / Collaborators

    Lead Sponsor: Indonesia University
    Responsible Party: N/A

    Location

    DKI Jakarta, Indonesia
    Jakarta Pusat, DKI Jakarta, Indonesia

    Combination of propofol and ketamine (ketofol) has been used as a medication for sedation in various medical procedures such as Endoscopic Retrograde Cholangio-pancreatography (ERCP). The addition of ketamine to propofol may counteract the effect of respiratory and cardiovascular depression of propofol. There has been limited studies evaluating the sedation effect of different ketofol dose ratios associated with hemodynamic changes, recovery time, dose and side effect. Thus, the study was aimed to compare the effect of ketofol between 6:1 and 4:1 ratio in patients who underwent ERCP

    Participant Groups

    • Patients in K61 group received propofol and ketamine in a ratio of 6:1. The 6:1 ketofol mixture was made by mixing 30 mL of 1% propofol (10 mg/mL) and 1 mL of ketamine (50 mg/ml), then 19 mL of 0.9% NaCl was added until the volume of the mixture was 50 mL. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun).

    • Patients in K41 group received propofol and ketamine in a ratio of 4:1. The 4:1 ketofol mixture was made by combining 20 mL of 1% propofol (10 mg/mL) and 1 mL ketamine (50 mg/ml). Afterward, 29 mL of 0.9% NaCl was added until the volume of mixture was 50 mL. Mixtures were mixed in a 50 mL syringe and were given to patients through a syringe pump (B Braun).

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Having ERCP procedures using sedatives
    * ASA (American Society of Anesthesiologist) physical status Class I to III
    * Body mass index (BMI) of 18-30 kg/m2
    * Willing to participate in the study

    Exclusion Criteria:

    * Patients with a history of allergic reaction to medications used in the study
    * Patients with cardiovascular disease, uncontrolled hypertension, respiratory dysfunction
    * Patients with unstable hemodynamic
    * Patients with psychiatric medications
    * Patients with probability of difficult intubation and ventilation Patients with kidney disorder Pregnant women

    Primary Outcomes

    • Level of propofol needed during the procedure

    Secondary Outcomes

    • Time needed to recover after the procedure

    More Details

    NCT Number: NCT04029831
    Other IDs: IndonesiaUAnes038
    Study URL: https://clinicaltrials.gov/study/NCT04029831
    Last updated: Sep 29, 2023