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Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation

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ClinicalTrials.gov Identifier: NCT02256358
Recruitment Status : Completed
First Posted : October 3, 2014
Results First Posted : October 9, 2014
Last Update Posted : October 20, 2014
Sponsor:
Information provided by (Responsible Party):
Ki Hwa Lee, Inje University

Tracking Information
First Submitted Date  ICMJE October 1, 2014
First Posted Date  ICMJE October 3, 2014
Results First Submitted Date  ICMJE October 6, 2014
Results First Posted Date  ICMJE October 9, 2014
Last Update Posted Date October 20, 2014
Study Start Date  ICMJE January 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2014)
Emergence Agitation [ Time Frame: During 30 minutes after extubation at post-anesthetic care unit, every 5 minutes ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2014)
Emergence agitation [ Time Frame: 30 minutes after extubation at post-anesthetic care unit ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation
Official Title  ICMJE Comparison of Effects of Intravenous Midazolam and Ketamine on Emergence Agitation : a Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Psychomotor Agitation
Intervention  ICMJE
  • Drug: Midazolam
    preoperatively injected intravenous 0.1 mg/kg midazolam
  • Drug: Ketamine
    Preoperatively injected intravenous 1mg/kg ketamine
    Other Name: Ketamine HCl
Study Arms  ICMJE
  • Active Comparator: Midazolam
    Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.
    Intervention: Drug: Midazolam
  • Experimental: Ketamine
    Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.
    Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 1, 2014)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02256358
Other Study ID Numbers  ICMJE 2012-127
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ki Hwa Lee, Inje University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inje University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kihwa Lee, MD Haeundae paik hospital, inje university
PRS Account Inje University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP