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

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ClinicalTrials.gov Identifier: NCT02646709
Recruitment Status : Unknown
Verified January 2016 by Go Un Roh, Ajou University School of Medicine.
Recruitment status was:  Not yet recruiting
First Posted : January 6, 2016
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
Go Un Roh, Ajou University School of Medicine

Tracking Information
First Submitted Date  ICMJE December 28, 2015
First Posted Date  ICMJE January 6, 2016
Last Update Posted Date January 6, 2016
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
Intubation Condition [ Time Frame: during and after intubation, about 2 minute ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2016)
  • heart rate [ Time Frame: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation ]
    heart rate will be recorded.
  • time for extubation [ Time Frame: from the end of surgery to extubation, within 10 min ]
  • emergence agitation (4 points scale) [ Time Frame: 5 min after postanesthesia care unit (PACU) admission ]
    4 points scale 1: calm 2. cry but manageable 3. cry, not manageable 4. excitation
  • PACU time [ Time Frame: from PACU admission to discharge, about 30 min ]
  • severity of vomiting [ Time Frame: 1. 1 min after PACU admission 2. 30 min after PACU admission ]
    severity(0-10)
  • Analgesic requirements (mg/kg) [ Time Frame: during PACU stay, about 30 min ]
    if pain score exceed 3, fentanyl will be introduced. The total dose of fentanyl injection will be recorded.
  • Desaturation [ Time Frame: during PACU stay, about 30 min ]
    pulseoximeter will be applied and peripheral oxygen saturation less than 94 will be recorded.
  • blood pressure [ Time Frame: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation ]
    blood pressure will be recorded
  • frequency of vomiting [ Time Frame: 1. 1 min after PACU admission 2. 30 min after PACU admission ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Different Dose of Ketamine With Low Dose Rocuronium in Children
Official Title  ICMJE The Effect of Different Doses of Ketamine on Tracheal Intubating Conditions Using Low Dose Rocuronium in Children
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Inguinal Hernia
Intervention  ICMJE
  • Drug: Rocuronium
    Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.
  • Drug: ketamine 1
    ketamine 1 mg/kg will be injected for induction of anesthesia
  • Drug: ketamine 1.5
    ketamine 1.5 mg/kg will be injected for induction of anesthesia
  • Drug: ketamine 2
    ketamine 2 mg/kg will be injected for induction of anesthesia
Study Arms  ICMJE
  • Experimental: Ketamine 1
    Ketamine 1 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
    Interventions:
    • Drug: Rocuronium
    • Drug: ketamine 1
  • Experimental: Ketamine 1.5
    Ketamine 1.5 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
    Interventions:
    • Drug: Rocuronium
    • Drug: ketamine 1.5
  • Experimental: Ketamine 2
    Ketamine 2 mg/kg will be injected during induction. Low dose rocuronium (0.3 mg/kg) will be injected for muscle relaxation.
    Interventions:
    • Drug: Rocuronium
    • Drug: ketamine 2
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 4, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA class I, II

Exclusion Criteria:

  • upper respiratory infection within 14 days
  • anticipated difficult intubation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 12 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 NCT02646709
Other Study ID Numbers  ICMJE AJIRB-MED-CT4-15-153
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Go Un Roh, Ajou University School of Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ajou University School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Go Un Roh, MD Ajou University School of Medicine
PRS Account Ajou University School of Medicine
Verification Date January 2016

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