The Effect of Different Dose of Ketamine With Low Dose Rocuronium in Children

Ketamine

Brief Summary

Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. For better intubating condition, ketamine can be used. However, appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.

Intervention / Treatment

  • Rocuronium (DRUG)
    Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.
  • Ketamine 1 (DRUG)
    ketamine 1 mg/kg will be injected for induction of anesthesia
  • ketamine 1.5 (DRUG)
    ketamine 1.5 mg/kg will be injected for induction of anesthesia
  • Ketamine 2 (DRUG)
    ketamine 2 mg/kg will be injected for induction of anesthesia

Condition or Disease

  • Inguinal Hernia

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 2 Years to 12 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized

    Masking

    TRIPLE:
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2016
    Primary Completion: May 01, 2016 ESTIMATED
    Completion Date: May 01, 2016 ESTIMATED
    Study First Posted: Jan 06, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 04, 2016

    Sponsors / Collaborators

    Lead Sponsor: Ajou University School of Medicine
    Responsible Party: N/A

    Participant Groups

    • Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.

    • Ketamine 1.5 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.

    • Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * ASA class I, II

    Exclusion Criteria:

    * upper respiratory infection within 14 days
    * anticipated difficult intubation

    Primary Outcomes

    • 5 variables will be individually evaluated though 3 point scale (excellent, good, poor). If all variables are graded as excellent, intubation condition will be excellent. If at least 1 variable is poor, it will be reported as poor. Otherwise, it will be reported as good. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing

    Secondary Outcomes

    • heart rate will be recorded.

    • time for extubation from the end of surgery to extubation, within 10 min

    • 4 points scale 1: calm 2. cry but manageable 3. cry, not manageable 4. excitation

    • PACU time from PACU admission to discharge, about 30 min

    • severity(0-10)

    • if pain score exceed 3, fentanyl will be introduced. The total dose of fentanyl injection will be recorded.

    • pulseoximeter will be applied and peripheral oxygen saturation less than 94 will be recorded.

    • blood pressure will be recorded

    • frequency of vomiting 1. 1 min after PACU admission 2. 30 min after PACU admission

    More Details

    NCT Number: NCT02646709
    Other IDs: AJIRB-MED-CT4-15-153
    Study URL: https://clinicaltrials.gov/study/NCT02646709
    Last updated: Sep 29, 2023