Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure

Not Applicable

Completed

• Conditions: Congenital Pulmonary Stenosis
• Interventions: Diagnostic Test: induction of anesthesia

• Registration Number: NCT05582213
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-17
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age from 1 month to 1 year.
2. Both gender
3. Isolated congenital pulmonary stenosis

Exclusion Criteria

1. Multiple cardiac congenital anomalies.
2. Previous open-heart surgery.
3. Other non-cardiac congenital anomalies
4. Refusal of parents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group ketamine:	induction of anesthesia	This group includes (20) patients will receive ketamine 2 mg/kg intravenous for induction of sedation and unconsciousness
classic group (CL group)	induction of anesthesia	20 patients will be enrolled to induction with sevofloran as inhalational anesthetics

Primary Outcome Measures

Name	Time	Method
right ventricular pressure	baseline	right ventricular pressure before induction of anesthesia

Secondary Outcome Measures

Name	Time	Method
vital data	baseline	Spo2 in both group

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt