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临床试验/CTRI/2024/04/066383
CTRI/2024/04/066383招募中3 期

Comparison of thoracic segmental spinal anesthesia with intravenous dexmedetomidine for haemodynamic responses in laparoscopic cholecystectomy-a randomised controlled trial.

IMS AND SUM HOSPITAL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月10日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Mean blood pressure, heart rate

研究概览

简要总结

Laparoscopy has now become the standard technique of choice for cholecystectomy. The hallmark of laparoscopy is the creation of pneumoperitoneum which leads to stimulation of the sympathetic nervous system characterised by increase in arterial pressure and systemic and pulmonary vascular resistance with change in heart rate (HR).

Dexmedetomidine is used for blunting the stress responses during critical events such as laryngoscopy, endotracheal intubation, pneumoperitoneum creation, and extubation. Thoracic segmental spinal anesthesia is better with general anesthesia  due to good abdominal relaxation, good hemodynamic stability  alongwith decreased requirement of muscle relaxant and better extubating conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor 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

  • PATIENTS UNDERGOING LAPAROSCOPY CHOLECYSTECTOMY ASA 1 AND 2.

排除标准

  • associated systemic comorbidities like cardiovascular diseases, respiratory diseases, renal diseases, pregnant or lactating mother or any medications like beta blockers, anti-arrhthmics, antipsychotics or steroids.

结局指标

主要结局

Mean blood pressure, heart rate

时间窗: at baseline, trocar insertion, pneumperitoneum 5 minutes (P5) , 10 minutes (P10), 15 minutes (P15), 30 minutes (P30). 5 minutes after the release of CO2 (R5), and 5 minutes after extubation

次要结局

  • The overall quality of intraoperative muscle relaxation (poor, fair, good, or excellent) was evaluated by the surgeon at the end of the surgery.(Intraoperative requirement of muscle relaxation according to TOF)

研究者

发起方
IMS AND SUM HOSPITAL
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Bhavna sriramka

IMS AND SUM HOSPITAL

研究点 (1)

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