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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. Identifier: NCT01501786
Recruitment Status : Completed
First Posted : December 29, 2011
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
Kazuhiko Okuyama, MD, Ibaraki Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Sedated for Cardiac Catheterization Drug: control Drug: Ket10 Drug: Ket20 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization
Study Start Date : January 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Sham Comparator: control
propofol and saline are administered
Drug: control
propofol 8mg/kg/h saline 0.24 ml/kg/h
Other Name: saline with propofol

Experimental: Ket10
ketamine is co-administered with propofol
Drug: Ket10
propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
Other Name: ketamine 10 γ

Experimental: Ket20
ketamine is co-administered with porpofol
Drug: Ket20
propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
Other Name: ketamine 20 γ

Primary Outcome Measures :
  1. difference of end tidal partial pressure of carbon dioxide between the groups [ Time Frame: 30 and 60 min after anesthetic induction ]
  2. difference of partial pressure of arterial carbon dioxide between the groups [ Time Frame: 60 min after anesthetic induction on average ]
  3. heart rate change from baseline value [ Time Frame: 30 and 60 min after anesthetic induction ]
  4. non-invasive blood pressure change from baseline value [ Time Frame: 30 and 60 min after anesthetic induction ]

Secondary Outcome Measures :
  1. 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)

  2. 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 ]

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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01501786

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Ibaraki Children's Hospital
Mito, Ibaraki, Japan, 311-4145
Sponsors and Collaborators
Ibaraki Children's Hospital
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Study Chair: Kazuhiko Okuyama, MD Ibaraki Children's Hospital
Principal Investigator: Yuki Takeda, MD Ibaraki Children's Hospital
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Responsible Party: Kazuhiko Okuyama, MD, Head of Anesthesiology department, Ibaraki Children's Hospital Identifier: NCT01501786    
Other Study ID Numbers: ketamine in sedation
First Posted: December 29, 2011    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013
Keywords provided by Kazuhiko Okuyama, MD, Ibaraki Children's Hospital:
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action