Remifentanil Requirement for Acceptable Intubating Condition

Ketamine

Brief Summary

Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.

Intervention / Treatment

  • Ketamine 1 (DRUG)
    Anesthesia induction is performed with 1 mg ketamine.
  • Ketamine 2 (DRUG)
    Anesthesia induction is performed with 2 mg ketamine.
  • Remifentanil (DRUG)
    After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.

Condition or Disease

  • Intubating Condition

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 3 Years to 12 Years
    Enrollment: 51 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Jun 19, 2017 ACTUAL
    Primary Completion: Apr 16, 2018 ACTUAL
    Completion Date: Apr 16, 2018 ACTUAL
    Study First Posted: Jan 14, 2016 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Jan 08, 2019

    Sponsors / Collaborators

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

    Location

    South Korea
    Gyeong-gi Do, South Korea

    Participant Groups

    • Anesthesia induction with ketamine 1 mg followed by remifentanil.

    • Anesthesia induction with ketamine 2 mg followed by remifentanil.

    Eligibility Criteria

    Sex: All
    Minimum Age: 3
    Maximum Age: 12
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * ASA I-II
    * Undergoing general anesthesia with endotracheal tube

    Exclusion Criteria:

    * Anticipated difficult airway
    * Patient with upper respiratory infection within 14 days
    * Asthma

    Primary Outcomes

    • For assessment of intubation condition, 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. Good and excellent will be considered to be acceptable intubating condition. Poor will be reported as unacceptable intubating condition. 1. Laryngoscope easiness 2. Vocal cord position 3. Vocal cord movement 4. Movement of limb 5. Coughing

    More Details

    NCT Number: NCT02655380
    Other IDs: MED-DRU-15-354
    Study URL: https://clinicaltrials.gov/study/NCT02655380
    Last updated: Sep 29, 2023