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临床试验/CTRI/2025/01/079635
CTRI/2025/01/079635尚未招募不适用

A randomised clinical trial on the effects of two different doses of dexmedetomidine infusion on haemodynamic stress response, sedation and postoperative analgesia requirement in patients undergoing laparoscopic cholecystectomy.

Sukanta Saha1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年2月10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
64
试验地点
1
主要终点
Haemodynamic changes (hypertension, bradycardia) and sedation effect.

研究概览

简要总结

The study will be conducted on “A randomised clinical trial on the effects of two different doses of dexmedetomidine infusion on haemodynamic stress response, sedation and post-operative analgesia requirement in patients undergoing laparoscopic cholecystectomy”. Here, in our study we will compare the infusion of two low doses of dexmedetomidine with an aim to assess the effect on haemodynamic stress response, sedation during the surgical procedure. We will also try to find out the post-operative analgesia requirement. A total of 64, aged 18 to 65 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing laparoscopic cholecystectomy under general anaesthesia will be divided into two groups (Group A, group B) by block randomization. Group A patients will receive dexmedetomidine 0.2 mcg/kg/h as intravenous infusion, group B patients will receive dexmedetomidine 0.4 mcg/kg/h as intravenous infusion. Hemodynamic parameters will be monitored and recorded during before starting the infusion, 15 min after starting the infusion, after induction, after intubation, after creation and release of pneumoperitoneum and after extubation. Patients were also observed for time to extubate trachea, post-operative sedation level, time to first rescue analgesic requirement, total amount of analgesic drug required during the first 24 h post-operatively and the adverse effects. The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn.

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 65.00 Year(s)(—)
性别
All

入选标准

  • Patient of age group 18-65 yrs.
  • Patient with American society of Anesthesiologists (ASA) physical grade I or II.

排除标准

  • Patient who refused to give consent.
  • Local site infection.
  • History of allergy to study drugs specially amide group of drugs.
  • patient taking any analgesic and anticoagulant (bleeding tendencies).
  • uncontrolled cardiovascular, central nervous system, respiratory system comorbidities and kidney disorders.
  • Psychiatric patients.
  • Anticipated difficult intubation.

结局指标

主要结局

Haemodynamic changes (hypertension, bradycardia) and sedation effect.

时间窗: Haemodynamic changes (hypertension, bradycardia), sedation effect and sedation score (15 min, 30 min, 45 min, 60 min, 120 min).

次要结局

  • Post-operative analgesia requirements.(We will observe total analgesic requirement on patient demand in 24 hours post-operative period.)

研究者

发起方
Sukanta Saha
申办方类型
Other [Post Graduate Trainee]
责任方
Principal Investigator
主要研究者

Sukanta Saha

Regional Institute of Medical Sciences Imphal

研究点 (1)

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