Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

NCT ID: NCT01501786

Last Updated: 2013-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-05-31

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.

Conditions

Congenital Heart Disease; Sedated for Cardiac Catheterization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

control

propofol and saline are administered

Group Type: SHAM_COMPARATOR

control

Intervention Type: DRUG

propofol 8mg/kg/h saline 0.24 ml/kg/h

Ket10

ketamine is co-administered with propofol

Group Type: EXPERIMENTAL

Ket10

Intervention Type: DRUG

propofol 6.4 mg/kg/h ketamine 10 microg/kg/min

Ket20

ketamine is co-administered with porpofol

Group Type: EXPERIMENTAL

Ket20

Intervention Type: DRUG

propofol 4.8 mg/kg/h ketamine 20 microg/kg/min

Interventions

control

propofol 8mg/kg/h saline 0.24 ml/kg/h

Intervention Type: DRUG

Ket10

propofol 6.4 mg/kg/h ketamine 10 microg/kg/min

Intervention Type: DRUG

Ket20

propofol 4.8 mg/kg/h ketamine 20 microg/kg/min

Intervention Type: DRUG

Other Intervention Names

saline with propofol; ketamine 10 γ; ketamine 20 γ

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ibaraki Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kazuhiko Okuyama, MD

Head of Anesthesiology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kazuhiko Okuyama, MD

Role: STUDY_CHAIR

Ibaraki Children's Hospital

Yuki Takeda, MD

Role: PRINCIPAL_INVESTIGATOR

Ibaraki Children's Hospital

Locations

Ibaraki Children's Hospital

Mito, Ibaraki, Japan

Countries

Japan

Other Identifiers

ketamine in sedation

Identifier Type: -

Identifier Source: org_study_id