跳至主要内容
临床试验/CTRI/2023/09/057270
CTRI/2023/09/057270尚未招募2/3 期

A randomised controlled trial to compare the effect of intravenous clonidine versus dexmedetomidine on hemodynamic response to pneumoperitoneum during laparoscopic cholecystectomy

Sri Guru Ram Das Institute of Medical sciences and Research1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年9月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare the effect of intravenous clonidine versus intravenous dexmedetomidine on pneumoperitoneum-induced hemodynamic response during laparoscopic cholecystectomy

研究概览

简要总结

Background: Laparoscopic cholecystectomy is the treatment of choice for symptomatic benign gall bladder diseases and has essentially replaced the open technique because of its better postoperative recovery profile. But it is also associated with significant cardiopulmonary changes due to the pressure effect of pneumoperitoneum and the release of catecholamine. Various drugs have been used to prevent these responses like magnesium sulfate, nitroglycerine, clonidine, and dexmedetomidine. Clonidine, a selective alpha-2 adrenergic agonist, and dexmedetomidine, a new generation highly selective alpha-2 adrenoreceptor agonist, inhibit catecholamine release effectively and will be used in this study for achieving haemodynamic stability.

Objectives: To compare the effect of intravenous clonidine versus intravenous dexmedetomidine on pneumoperitoneum-induced hemodynamic response during laparoscopic cholecystectomy.

Material And Methods: in three groups of 30 each randomly selected patients, one group will receive 50 ml of normal saline, the second group will receive 0.75μg/kg clonidine in normal saline, the third group will receive 0.75μg/kg dexmedetomidine in normal saline and total volume of study drug will be adjusted to 50 ml each administrated for 15 minutes before induction of GA.

Expected Benefits: in terms of stable hemodynamics, reduction in induction dose of propofol, decreased post-operative pain, and decreased side effects.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • ASA grades I and II.

排除标准

  • Patients not giving consent
  • Any heart block, preexisting hypertension, cardiovascular disease
  • Hepatic and renal disease
  • Allergies to the drugs used
  • Acute cholecystitis
  • Pregnant ladies and lactating mothers
  • Patients taking clonidine, methyl-dopa, beta-blocking drugs, benzodiazepines, MAO inhibitors
  • Morbidly obese
  • Open cholecystectomy.

结局指标

主要结局

To compare the effect of intravenous clonidine versus intravenous dexmedetomidine on pneumoperitoneum-induced hemodynamic response during laparoscopic cholecystectomy

时间窗: from the giving of study drug till the end of the study

次要结局

  • 1) Effect of intravenous clonidine on hemodynamic response during laparoscopic cholecystectomy(2) Effect of intravenous dexmedetomidine on hemodynamic response during laparoscopic cholecystectomy)

研究者

发起方
Sri Guru Ram Das Institute of Medical sciences and Research
申办方类型
Research institution and hospital

研究点 (1)

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