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Effect of Ketamine Versus Sevoflurane On The Right Ventricular Pressure

A

Ain Shams University

Status

Completed

Conditions

Congenital Pulmonary Stenosis

Treatments

Diagnostic Test: induction of anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05582213
congenital pulmonary stenosis

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

1 month to 1 year old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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