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Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

This study has been completed.
Information provided by (Responsible Party):
Kazuhiko Okuyama, MD, Ibaraki Children's Hospital Identifier:
First received: December 10, 2011
Last updated: July 28, 2013
Last verified: July 2013
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 Intervention
Congenital Heart Disease
Sedated for Cardiac Catheterization
Drug: control
Drug: Ket10
Drug: Ket20

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Ibaraki Children's Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: January 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
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Please refer to this study by its identifier: NCT01501786

Ibaraki Children's Hospital
Mito, Ibaraki, Japan, 311-4145
Sponsors and Collaborators
Ibaraki Children's Hospital
Study Chair: Kazuhiko Okuyama, MD Ibaraki Children's Hospital
Principal Investigator: Yuki Takeda, MD Ibaraki Children's Hospital
  More Information

Responsible Party: Kazuhiko Okuyama, MD, Head of Anesthesiology department, Ibaraki Children's Hospital Identifier: NCT01501786     History of Changes
Other Study ID Numbers: ketamine in sedation
Study First Received: December 10, 2011
Last Updated: July 28, 2013

Keywords provided by Ibaraki Children's Hospital:

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Behavioral Symptoms
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 processed this record on April 28, 2017