Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure

Study Overview
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Brief Summary
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The aim of this study is to compare the effect of different anesthetic drugs used for induction of anesthesia ketamine versus sevoflurane on the RV pressure in pediatrics undergoing balloon dilatation for congenital pulmonary stenosis.

Detailed Description
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Critical pulmonary stenosis (PS) is a life-threatening congenital heart disease which manifest during the neonatal period with cyanosis. Surgical valvotomy was the procedure of choice for critical PS; however, balloon pulmonary valvoplasty (BPV) has now become the standard management. Ketamine is often used for procedural sedation or as adjunct agent for general anesthesia in pediatrics with congenital heart disease. Ketamine is a chemical derivative of phencyclidine acting as a selective antagonist of the N-methyl-d-aspartate (NMDA) receptor, an ionotropic glutamate receptor that participates in analgesia, amnesia, and sedation pathways. Ketamine has minimal impact on hemodynamics in children with congenital heart disease when used at usual clinical doses. Systemic vascular resistance and pulmonary vascular resistance are not significantly altered. Sevoflurane is a sweet-smelling, highly fluorinated methyl isopropyl ether used as an inhalational anesthetic for induction and maintenance of general anesthesia. It proved to be safe as induction agent in noncardiac surgery and cardiac surgery. Sevoflurane has low solubility in blood, produces less arrhythmias and decrease in contractility less than halothane without changing pulmonary to systemic blood flow ratio in pediatrics with congenital heart disease.

Official Title
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Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure During Congenital Pulmonary Stenosis Balloon Dilatation

Conditions
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Congenital Pulmonary Stenosis

Intervention / Treatment
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* Diagnostic Test: induction of anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age from 1 month to 1 year. Both gender Isolated congenital pulmonary stenosis Exclusion Criteria: Multiple cardiac congenital anomalies. Previous open-heart surgery. Other non-cardiac congenital anomalies Refusal of parents

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 1 Year

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: classic group (CL group)<br>20 patients will be enrolled to induction with sevofloran as inhalational anesthetics | Diagnostic Test: induction of anesthesia<br>* This group includes (20) patients will receive induction by sevoflurane 3% using open circuit (modified Ayre's T-piece) till loss of consciousness and will be maintained on oxygen mask on the same concentration of sevoflurane and connected to capnogram<br>|
| Other: Group ketamine:<br>This group includes (20) patients will receive ketamine 2 mg/kg intravenous for induction of sedation and unconsciousness | Diagnostic Test: induction of anesthesia<br>* This group includes (20) patients will receive induction by sevoflurane 3% using open circuit (modified Ayre's T-piece) till loss of consciousness and will be maintained on oxygen mask on the same concentration of sevoflurane and connected to capnogram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right ventricular pressure | right ventricular pressure before induction of anesthesia | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital data | Spo2 in both group | baseline |