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临床试验/NCT05582213
NCT05582213已完成不适用

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

Ain Shams University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
right ventricular pressure

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
1 Month 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Multiple cardiac congenital anomalies.
  • Previous open-heart surgery.
  • Other non-cardiac congenital anomalies
  • Refusal of parents

结局指标

主要结局

right ventricular pressure

时间窗: baseline

right ventricular pressure before induction of anesthesia

次要结局

  • vital data(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Gaber

lecturer clinical doctor

Ain Shams University

研究点 (1)

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