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临床试验/CTRI/2025/02/080428
CTRI/2025/02/080428尚未招募不适用

To evaluate the effectiveness of intravenous dexmedetomidine infusion on intraoperative hemodynamics during laparoscopic surgery : A prospective randomised study

JLN medical college and hospital1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2025年2月22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
98
试验地点
1
主要终点
Effectiveness of perioperative iv dexmetadomidine on

研究概览

简要总结

This study aims to evaluate the effectiveness of intravenous dexmedetomidine infusion on intraoperative haemodynamics during laparoscopic surgeries. The study will be a prospective, double-blinded, randomized interventional study conducted at Jawaharlal Nehru Medical College and Associated Group of Hospitals, Ajmer.

The study will include 98 patients undergoing laparoscopic surgeries, randomly assigned to either a dexmedetomidine group or a control group. Dexmedetomidine will be administered intravenously as a bolus followed by an infusion, while the control group will receive normal saline.

The primary objective is to assess the impact of dexmedetomidine on haemodynamic parameters during various time intervals throughout the surgery. Secondary objectives include evaluating the drug’s effectiveness in reducing pressor response due to laryngoscopy, facilitating smooth extubation while maintaining haemodynamic stability, and observing any side effects like hypotension, bradycardia, or sedation.

The study’s findings will be analyzed using statistical methods to compare the haemodynamic response, sedation levels, and side effects between the two groups. The results will contribute to understanding the clinical benefits of dexmedetomidine for managing haemodynamic instability during laparoscopic surgeries and improving patient safety and recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged 18-60 years of either sex -Body weight 40-80 kilogram -ASA Grade first and second -Patients scheduled for laproscopic surgery and who are willing to give written and informed consent for general anaesthesia.

排除标准

  • Age less then 18 years and more then 60 years
  • ASA grade third and fourth
  • Patients not willing to participate in the study
  • Patients with a history of drug allergy
  • Patients with chronic pre-existing disease like Asthma, Renal or Hepatic dysfunction, diabetes mellitus, neuro muscular diseases, severe respiratory diseases etc.
  • Pregnancy/Lactation.

结局指标

主要结局

Effectiveness of perioperative iv dexmetadomidine on

时间窗: Baseline

haemodynamic

时间窗: Baseline

次要结局

  • 1. Pressor response due to laryngoscopy(2. Smooth extubation with maintaing haemodynamic stability)

研究者

发起方
JLN medical college and hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Veena Patodi

JLN medical college and hospital

研究点 (1)

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