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Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05582213
Enrollment
40
Registered
2022-10-17
Start date
2022-10-01
Completion date
2023-02-10
Last updated
2023-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Pulmonary Stenosis

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.

Interventions

DIAGNOSTIC_TESTinduction of anesthesia

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Months to 1 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
right ventricular pressurebaselineright ventricular pressure before induction of anesthesia

Secondary

MeasureTime frameDescription
vital databaselineSpo2 in both group

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026