Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions

Study Overview
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Brief Summary
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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.

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

Conditions
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Congenital Heart Disease, Sedated for Cardiac Catheterization

Intervention / Treatment
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* Drug: control
* Drug: Ket10
* Drug: Ket20


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: control<br>propofol and saline are administered | Drug: control<br>* propofol 8mg/kg/h saline 0.24 ml/kg/h<br>* Other names: saline with propofol;|
| Experimental: Ket10<br>ketamine is co-administered with propofol | Drug: Ket10<br>* propofol 6.4 mg/kg/h ketamine 10 microg/kg/min<br>* Other names: ketamine 10 γ;|
| Experimental: Ket20<br>ketamine is co-administered with porpofol | Drug: Ket20<br>* propofol 4.8 mg/kg/h ketamine 20 microg/kg/min<br>* Other names: ketamine 20 γ;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, sedation, propofol, ketamine