Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

Congenital Heart Disease Clinical Trial

Official title:

The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01501786
• Other study ID #: ketamine in sedation
• Status: Completed
• Phase: N/A
• First received: December 10, 2011
• Last updated: July 28, 2013
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Ibaraki Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Sedated for Cardiac Catheterization

Intervention

Drug:
• control
propofol 8mg/kg/h saline 0.24 ml/kg/h
• Ket10
propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
• Ket20
propofol 4.8 mg/kg/h ketamine 20 microg/kg/min

Locations

Country	Name	City	State
Japan	Ibaraki Children's Hospital	Mito	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Ibaraki Children's Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of end tidal partial pressure of carbon dioxide between the groups		30 and 60 min after anesthetic induction	No
Primary	difference of partial pressure of arterial carbon dioxide between the groups		60 min after anesthetic induction on average	No
Primary	heart rate change from baseline value		30 and 60 min after anesthetic induction	No
Primary	non-invasive blood pressure change from baseline value		30 and 60 min after anesthetic induction	No
Secondary	movement at topical anesthetic injection	none (no movement or slight movement unnecessary to restrain); mild (movement necessary to restrain, limited to lower extremities); moderate (strong movement of lower extremities and movement of upper extremities unvecessary to restrain); severe (movement necessary to restrain upper extremities and body trunk in addition to lower extremities, or some vacalization)	20 min after anesthetic induction on average	No
Secondary	the number of times that secreted saliva is aspirated by an attending anesthesiologist		From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction	No