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Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

Primary Purpose

Psychomotor Agitation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Midazolam
Ketamine
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychomotor Agitation focused on measuring child, ketamine, midazolam

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Midazolam

    Ketamine

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Emergence Agitation
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 1, 2014
    Last Updated
    October 9, 2014
    Sponsor
    Inje University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02256358
    Brief Title
    Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
    Official Title
    Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Inje University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Compare the effects of intravenous midazolam and ketamine on emergence agitation after sevoflurane anesthesia
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychomotor Agitation
    Keywords
    child, ketamine, midazolam

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Midazolam
    Arm Type
    Active Comparator
    Arm Description
    Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
    Arm Title
    Ketamine
    Arm Type
    Experimental
    Arm Description
    Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
    Intervention Type
    Drug
    Intervention Name(s)
    Midazolam
    Intervention Description
    preoperatively injected intravenous 0.1 mg/kg midazolam
    Intervention Type
    Drug
    Intervention Name(s)
    Ketamine
    Other Intervention Name(s)
    Ketamine HCl
    Intervention Description
    Preoperatively injected intravenous 1mg/kg ketamine
    Primary Outcome Measure Information:
    Title
    Emergence Agitation
    Description
    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.
    Time Frame
    During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    6 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kihwa Lee, MD
    Organizational Affiliation
    Haeundae paik hospital, inje university
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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