Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01501786
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : July 30, 2013
Sponsor:
Information provided by (Responsible Party):
Kazuhiko Okuyama, MD, Ibaraki Children's Hospital

Tracking Information
First Submitted Date  ICMJE December 10, 2011
First Posted Date  ICMJE December 29, 2011
Last Update Posted Date July 30, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2011)
  • difference of end tidal partial pressure of carbon dioxide between the groups [ Time Frame: 30 and 60 min after anesthetic induction ]
  • difference of partial pressure of arterial carbon dioxide between the groups [ Time Frame: 60 min after anesthetic induction on average ]
  • heart rate change from baseline value [ Time Frame: 30 and 60 min after anesthetic induction ]
  • non-invasive blood pressure change from baseline value [ Time Frame: 30 and 60 min after anesthetic induction ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 26, 2011)
  • movement at topical anesthetic injection [ Time Frame: 20 min after anesthetic induction on average ]
    1. none (no movement or slight movement unnecessary to restrain)
    2. mild (movement necessary to restrain, limited to lower extremities)
    3. moderate (strong movement of lower extremities and movement of upper extremities unvecessary to restrain)
    4. severe (movement necessary to restrain upper extremities and body trunk in addition to lower extremities, or some vacalization)
  • the number of times that secreted saliva is aspirated by an attending anesthesiologist [ Time Frame: From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction ]
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 Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions
Official Title  ICMJE The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization
Brief Summary Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Congenital Heart Disease
  • Sedated for Cardiac Catheterization
Intervention  ICMJE
  • Drug: control
    propofol 8mg/kg/h saline 0.24 ml/kg/h
    Other Name: saline with propofol
  • Drug: Ket10
    propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
    Other Name: ketamine 10 γ
  • Drug: Ket20
    propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
    Other Name: ketamine 20 γ
Study Arms  ICMJE
  • Sham Comparator: control
    propofol and saline are administered
    Intervention: Drug: control
  • Experimental: Ket10
    ketamine is co-administered with propofol
    Intervention: Drug: Ket10
  • Experimental: Ket20
    ketamine is co-administered with porpofol
    Intervention: Drug: Ket20
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: December 26, 2011)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization

Exclusion Criteria:

  • patients who have neurological disease,
  • endocrinological disease,
  • airway anomaly, who require positive pressure ventilation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01501786
Other Study ID Numbers  ICMJE ketamine in sedation
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kazuhiko Okuyama, MD, Ibaraki Children's Hospital
Study Sponsor  ICMJE Ibaraki Children's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kazuhiko Okuyama, MD Ibaraki Children's Hospital
Principal Investigator: Yuki Takeda, MD Ibaraki Children's Hospital
PRS Account Ibaraki Children's Hospital
Verification Date July 2013

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