Use of Ketamine Prior to Cardiopulmonary Bypass in Children

This study has been completed.
Information provided by:
Arkansas Children's Hospital Research Institute Identifier:
First received: November 9, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.

Condition Intervention Phase
Ventricular Septal Defect
Drug: saline
Drug: ketamine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Resource links provided by NLM:

Further study details as provided by Arkansas Children's Hospital Research Institute:

Primary Outcome Measures:
  • To compare expression of serum markers of CNS injury [ Time Frame: within 48 hours ]
  • to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls. [ Time Frame: within 48 hours ]

Secondary Outcome Measures:
  • to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls [ Time Frame: one month ]

Enrollment: 24
Study Start Date: July 2004
Study Completion Date: November 2007
Arms Assigned Interventions
Placebo Comparator: 1 Drug: saline
2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass
Experimental: 2 Drug: ketamine
2 mg/Kg IV within 5 minutes of cardiopulmonary bypass


Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • less than one year of age
  • undergoing cardiac surgery for repair of ventricular septal defect
  • requiring cardiopulmonary bypass
  • not requiring retrogrades cerebral perfusion

Exclusion Criteria:

  • Downs Syndrome
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Please refer to this study by its identifier: NCT00556361

United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Principal Investigator: Adnan T Bhutta, MD Arkansas Children's Hospital Research Institute
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00556361     History of Changes
Other Study ID Numbers: 28781 Bhutta  CUMG 
Study First Received: November 9, 2007
Last Updated: November 9, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Septal Defects
Heart Septal Defects, Ventricular
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 23, 2016