Comparison Between Efficacy of Ketamine and Propofol Mixture With 1:6 Ratio and 1:4 Ratio for Endoscopic Retrograde Procedure Sedation

Ketamine

Brief Summary

This study aimed to compare the efficacy of ketamine and propofol mixture with 1:6 ratio and 1:4 ratio for endoscopic retrograde procedure

Intervention / Treatment

  • ketamine and propofol mixture with 1:6 ratio (DRUG)
    K16: K16 group was received ketamine:propofol with ratio of 1:6, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 30 ml of 1% propofol (10 mg/ml), and 19 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 6 mg of propofol
  • ketamine and propofol mixture with 1:4 ratio (DRUG)
    K14 group was received ketamine:propofol with ratio of 1:4, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 20 ml of 1% propofol (10 mg/ml), and 29 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 4 mg of propofol

Condition or Disease

  • Adult Patients Undergoing ERCP

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

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    Clinical Trial Dates

    Start date: Mar 01, 2017 ACTUAL
    Primary Completion: Jun 30, 2017 ACTUAL
    Completion Date: Aug 31, 2017 ACTUAL
    Study First Posted: Jun 22, 2017 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 04, 2017

    Sponsors / Collaborators

    Lead Sponsor: Indonesia University
    Responsible Party: N/A

    Location

    DKI Jakarta, Indonesia
    Central Jakarta, DKI Jakarta, Indonesia

    Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Intravenous (IV) cannula (20 G) , non-invasive blood pressure monitor, and pulse-oxymetry had been set on the subjects in endoscopic room. Vital signs were recorded. Subjects were then randomized into two groups (Ketamine:propofol ratio of 1:6 \[K16\] and ketamine:propofol ratio of 1:4 \[K14\]). K16 group's drug mixture was ketamine:propofol with ratio of 1:6, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 30 ml of 1% propofol (10 mg/ml), and 19 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 6 mg of propofol. K14 group's drug mixture was ketamine:propofol with ratio of 1:4, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 20 ml of 1% propofol (10 mg/ml), and 29 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 4 mg of propofol. Patient then was given initial bolus dose of 1 mg/kg body weight (BW) (based on propofol dose) and continued with maintenance dose of propofol (50 mcg/kg BW/minute, based on propofol dose). Maintenance dose could be increased by 10 mcg/kg BW/ minute if the subject still gave response to surgical stimulation or decreased by 10 mcg/kg BW/minute if hypotension occured. Onset of the drug, vital signs every 5 minutes, hypotension and desaturation events were recorded. If there were signs of pain such as tachycardia or hypertension, an additional dose of 25 mcg of fentanyl intravenous was given and recorded. After the endoscopic retrograde cholangiopancreatography (ERCP) finished, drugs were stopped and the total doses of propofol, drug administration speed, total dose of fentanyl used, and recovery time were recorded. Subjects were moved to the recovery room and observed for side effects event. Subjects were moved to the ward after aldrete score of 9-10.

    Participant Groups

    • K16 group was received ketamine:propofol with ratio of 1:6, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 30 ml of 1% propofol (10 mg/ml), and 19 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 6 mg of propofol

    • K14 group was received ketamine:propofol with ratio of 1:4, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 20 ml of 1% propofol (10 mg/ml), and 29 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 4 mg of propofol

    Eligibility Criteria

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

    Inclusion Criteria:

    * Patients who were going to undergo ERCP unders sedation. Patient with American Society of Anesthesiologists (ASA) physical status of I-III, and body mass index of 18-30 kg/m2.

    Exclusion Criteria:

    * Subjects with history of allergy with drugs used in this trial, subjects with cardiovascular disease, hypertension, respiratory disorder, pregnancy, unstable hemodynamic, psychiatric drugs consumption, possibility of difficult airway, and kidney disorder

    Drop out Criteria:

    * drug allergy during procedure, hypotension (\>20%) not resolved using ephedrine, desaturation (oxygen saturation \<90%) not resolved using positive pressure ventilation, and endoscopic complication occur

    Primary Outcomes

    • Recovery time after procedure has ended

    • Total dose of propofol used during ERCP

    • Total dose of fentanyl used during ERCP

    More Details

    NCT Number: NCT03196479
    Other IDs: IndonesiaUAnes017
    Study URL: https://clinicaltrials.gov/study/NCT03196479
    Last updated: Sep 29, 2023