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临床试验/CTRI/2022/03/041499
CTRI/2022/03/041499尚未招募3 期

A Randomized Control Trial To Study The Effect Of Erector Spinae Plane Block On Hemodynamic Changes In Response To Pneumoperitoneum In Hypertensive Patients Undergoing Laparoscopic Cholecystectomy Under General Anaesthesia

Department of Anaesthesiology Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
The mean of hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure) in both groups.

研究概览

简要总结

Although the effect of erector spinae plane block on attenuation of hemodynamic parameters has been studied in non-laparoscopic surgeries such as lumbar spine surgery, but it has not been studied in laparoscopic surgeries to the best of our knowledge. Attenuating hemodynamic response to pneumoperitoneum is important for better patient outcome, especially in hypertensive population. Therefore, we have planned this study to study the effect of erector spinae plane block on the hemodynamic response to pneumoperitoneum in hypertensive patients undergoing laparoscopic cholecystectomy under general anaesthesia.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •All patients with age more than/equal to 18 years with controlled hypertension (systolic blood pressure less than/equal to 140mm Hg and diastolic blood pressure less than/equal to 90mm Hg).

排除标准

  • •a) Known allergy to any of the drugs used.
  • •(b) Impaired coagulation or on anticoagulant drugs.
  • •(c) Surgery converted to open cholecystectomy.
  • •(d) Surgery taking >3hrs.

结局指标

主要结局

The mean of hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure) in both groups.

时间窗: a) Baseline | (b) Before induction | (c) After intubation | (d) Before insufflation of carbon dioxide | (e) 10 minutes after creating pneumoperitoneum, and every 10 minutes thereafter. | (f) 10 minutes after exsufflation.

次要结局

  • Numerical rating scale for pain(0,6,12 and 24 hours)

研究者

发起方
Department of Anaesthesiology Lady Hardinge Medical College
申办方类型
Government medical college

研究点 (1)

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