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临床试验/CTRI/2025/07/092100
CTRI/2025/07/092100尚未招募4 期

Efficacy of preoperative paracetamol IV infusion versus diclofenac IV infusion in preventing shivering in patients undergoing lower abdominal surgery under spinal anaesthesia: A randomised controlled trial

Ballari Medical College and Research Center, ballari1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年8月16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
240
试验地点
1
主要终点
To compare the incidence of post spinal shivering in two groups

研究概览

简要总结

Title

Efficacy of Paracetamol IV Infusion versus Diclofenac IV Infusion in Preventing Shivering in Patients Undergoing Lower Abdominal Surgery under Spinal Anesthesia

Objective

To compare the efficacy of intravenous (IV) paracetamol and IV diclofenac in preventing shivering in patients undergoing lower abdominal surgery under spinal anesthesia.

Methodology

This study will likely involve a randomized controlled trial design, where patients are allocated to receive either IV paracetamol or IV diclofenac. The incidence and severity of shivering will be assessed and compared between the two groups.

Expected Outcome

The study aims to determine whether IV paracetamol or IV diclofenac is more effective in preventing shivering in patients undergoing lower abdominal surgery under spinal anesthesia, providing valuable insights for clinical practice.

Significance

Shivering is a common complication of spinal anesthesia, and effective prevention can improve patient comfort and outcomes. This study will contribute to the existing literature on the use of IV paracetamol and diclofenac for shivering prevention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and 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 lower abdominal surgery under spinal anaesthesia Patients belonging to ASA grade I.
  • II Patients with BMI 25.

排除标准

  • Patient refusal for study Any contra indication for spinal anaesthesia Allergy to study drugs Patients with severe systemic disorder Major Surgery where fluid shifts are expected Surgery prolonging more than 2 hours of duration.

结局指标

主要结局

To compare the incidence of post spinal shivering in two groups

时间窗: 5 mins,10 mins,15 mins,20 mins,30 mins,1 hour,2 hour

次要结局

  • 1)Time of Onset of shivering, 2)total number of intra operative and post operative episodes of shivering and duration of each episode(3)Severity of post spinal shivering)

研究者

发起方
Ballari Medical College and Research Center, ballari
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Pavitra L

Ballari Institute of medical sciences and research Center

研究点 (1)

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