Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Ketamine

Brief Summary

Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia

Intervention / Treatment

  • Midazolam (DRUG)
    preoperatively injected intravenous 0.1 mg/kg midazolam
  • Ketamine (DRUG)
    Preoperatively injected intravenous 1mg/kg ketamine

Condition or Disease

  • Psychomotor Agitation

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 2 Years to 6 Years
    Enrollment: 68 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jan 01, 2013
    Primary Completion: Jan 01, 2014 ACTUAL
    Completion Date: Jan 01, 2014 ACTUAL
    Study First Posted: Oct 03, 2014 ESTIMATED
    Results First Posted: Oct 09, 2014 ESTIMATED
    Last Updated: Oct 09, 2014

    Sponsors / Collaborators

    Lead Sponsor: Inje University
    Responsible Party: N/A

    Emergence agitation is self-limiting aggressive behavior that develops in the early period of awakening from anesthesia. A high level of preoperative anxiety is a risk factor for emergence agitation using Aono's four-point scale. Midazolam and ketamine was administered to the patients to decrease of preoperative anxiety. We aimed to compare the emergence agitation between midazolam group and ketamine group.

    Participant Groups

    • Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.

    • Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.

    Eligibility Criteria

    Sex: All
    Minimum Age: 2
    Maximum Age: 6
    Age Groups: Child
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * American society of anesthesiologists physical status 1-2 aged 2-6 years old, who were scheduled to undergo ophthalmic surgery (\<2hr)

    Exclusion Criteria:

    * children with central nervous system disorders,history of allergy to the study drugs (midazolam and ketamine), history of recent respiratory tract infection

    Primary Outcomes

    • The primary endpoint is the incidence of postoperative emergence agitation that was defined as an Aono's four-point scale(AFPS) score of 3 or higher.

    More Details

    NCT Number: NCT02256358
    Other IDs: 2012-127
    Study URL: https://clinicaltrials.gov/study/NCT02256358
    Last updated: Sep 29, 2023