Use of Ketamine Prior to Cardiopulmonary Bypass in Children

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00556361

Enrollment

Registered

2007-11-12

Start date

2004-07-31

Completion date

2007-11-30

Last updated

2007-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Septal Defect

Brief summary

To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.

Interventions

DRUGsaline

2 mg/Kg IV saline within 5 minutes of initiation of Cardiopulmonary bypass

DRUGketamine

2 mg/Kg IV within 5 minutes of cardiopulmonary bypass

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

No minimum to 1 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To compare expression of serum markers of CNS injury	within 48 hours
to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.	within 48 hours

Secondary

Measure	Time frame
to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls	one month

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026