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临床试验/CTRI/2025/08/093471
CTRI/2025/08/093471尚未招募4 期

A comparative evaluation between Dexmedetomidine and Esmolol for hemodynamic responses to pneumoperitoneum during laparoscopic cholecystectomy under general anesthesia in a tertiary care hospital in Sikkim- A double blinded randomized controlled study.

Sikkim Manipal Institute of Medical Science1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
To compare the efficacy of two study drugs, Dexmedetomidine and Esmolol in attenuating hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation) during pneumoperitoneum for patients undergoing laparoscopic cholecystectomy under general anesthesia.

研究概览

简要总结

A comparative evaluation between Dexmedetomidine and Esmolol for hemodynamic responses to pneumoperitoneum during Laparoscopic cholecystectomy under general anesthesia.

This research study aims to find out which medicines, i.e. Dexmedetomidine or Esmolol works better in keeping the heart rate, blood pressure, and oxygen levels stable when gas is pumped into the abdominal cavity during gallbladder surgery done under general anesthesia.

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
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 & ASA 2.

排除标准

  • Refusal to participate ASA 3 & ASA 4.

结局指标

主要结局

To compare the efficacy of two study drugs, Dexmedetomidine and Esmolol in attenuating hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and oxygen saturation) during pneumoperitoneum for patients undergoing laparoscopic cholecystectomy under general anesthesia.

时间窗: At the time of giving study drug then initiation of pneumoperitoneum and every 3 minutes after the pneumoperitoneum is established and for the first 15 minutes, then every 15 minutes for the first hour and every 30 minutes for the next 2 hours or until the pneumoperitoneum ends.

次要结局

  • Using Dexmedetomidine will reduce the chances of using any additional analgesic use.(During initiation of penumoperitoneum,every 3 minutes after the pneumoperitoneum is established and for the first 15 minutes, then every 15 minutes for the first hour and every 30 minutes for the next 2 hours or until the pneumoperitoneum ends.)

研究者

发起方
Sikkim Manipal Institute of Medical Science
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Awantika Rai

Sikkim Manipal Institute of Medical Science

研究点 (1)

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