Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Sedated for Cardiac Catheterization
• Interventions: Drug: control; Drug: Ket10; Drug: Ket20

• Registration Number: NCT01501786
• Lead Sponsor: Ibaraki Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-10
• Study First Submitted QC: 2011-12-26
• Study First Posted: 2011-12-29
• Study Start: 2012-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-28
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	propofol and saline are administered
Ket10	Ket10	ketamine is co-administered with propofol
Ket20	Ket20	ketamine is co-administered with porpofol

Primary Outcome Measures

Name	Time	Method
difference of end tidal partial pressure of carbon dioxide between the groups	30 and 60 min after anesthetic induction
difference of partial pressure of arterial carbon dioxide between the groups	60 min after anesthetic induction on average
heart rate change from baseline value	30 and 60 min after anesthetic induction
non-invasive blood pressure change from baseline value	30 and 60 min after anesthetic induction

Secondary Outcome Measures

Name	Time	Method
movement at topical anesthetic injection	20 min after anesthetic induction on average	1. none (no movement or slight movement unnecessary to restrain); 2. mild (movement necessary to restrain, limited to lower extremities); 3. moderate (strong movement of lower extremities and movement of upper extremities unvecessary to restrain); 4. severe (movement necessary to restrain upper extremities and body trunk in addition to lower extremities, or some vacalization)
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

Trial Locations

Locations (1)

Ibaraki Children's Hospital; 🇯🇵 Mito, Ibaraki, Japan