跳至主要内容
临床试验/CTRI/2024/08/071968
CTRI/2024/08/071968尚未招募不适用

A Prospective Observational Comparative Study Of Different Doses Of Remifentanil Infusion On Hemodynamics And Recovery In Children Undergoing Cardiac Catheterization

D Y Patil School Of Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
To study the effect of different doses of remifentanil on hemodynamics in pediatric population undergoing cardiac catheterization.

研究概览

简要总结

Remifentanil, a potent and short-acting opioid analgesic, has shown promising results in providing effective pain relief and sedation in various paediatric surgical procedures.

By examining the hemodynamic changes and recovery profiles associated with varying doses of remifentanil, this study aims to contribute valuable insights into the safe and effective use of this opioid analgesic in this particular patient population in cardiac catheterization.

Patients aged 5 years to 12 years undergoing Cardiac Catheterization will be assessed intraoperatively. Study is divided into 2 groups:

Group A -0.1mcg/kg/min and

Group B - 0.2mcg/kg/min.

Hemodynamic changes and recovery will be assessed in the study.

Premedication of intravenous midazolam will be given at the dose of 0.03mg/kg. Remifentanil infusion (Group A – 0.1 mcg/kg/min and Group B – 0.2 mcg/kg/min) will be started after noting the baseline vitals. Hemodynamic changes and analgesic effect of remifentanil during the entire procedure will be observed.

Propofol will be used as induction and maintenance agent and its dose and duration of requirement will be observed. Complications if any will be noted

研究设计

研究类型
Observational

入排标准

年龄范围
5.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Age group between 5 years to 12 years
  • Children fit for cardiac catheterization.

排除标准

  • 1.Parent’s refusal for consenting for cardiac catheterization.

结局指标

主要结局

To study the effect of different doses of remifentanil on hemodynamics in pediatric population undergoing cardiac catheterization.

时间窗: Sedation score every 5 minutes upto 60 minutes

次要结局

  • •To study the recovery (Consciousness and orientation) in patients undergoing cardiac catheterization.
  • To study the complications of remifentanil in paediatric cardiac catheterization(Monitor complications every 5 minutes till end of procedure)

研究者

发起方
D Y Patil School Of Medicine
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Akshay Harwalkar

D Y Patil School Of Medicine

研究点 (1)

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