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Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

I

Ibaraki Children's Hospital

Status

Completed

Conditions

Sedated for Cardiac Catheterization
Congenital Heart Disease

Treatments

Drug: Ket10
Drug: Ket20
Drug: control

Study type

Interventional

Funder types

Other

Identifiers

NCT01501786
ketamine in sedation

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

6 months to 10 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

150 participants in 3 patient groups

control
Sham Comparator group
Description:
propofol and saline are administered
Treatment:
Drug: control
Ket10
Experimental group
Description:
ketamine is co-administered with propofol
Treatment:
Drug: Ket10
Ket20
Experimental group
Description:
ketamine is co-administered with porpofol
Treatment:
Drug: Ket20

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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