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临床试验/CTRI/2025/09/094896
CTRI/2025/09/094896尚未招募不适用

The Effect of Preoperative Warming in Preventing Hypothermia and Shivering in Patients Undergoing Lower Abdominal Surgery in a Tertiary Care Hospital

Kodagu Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月29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
100
试验地点
1
主要终点
To determine the effect of preoperative warming on intraoperative hypothermia.

研究概览

简要总结

Hypothermia and shivering are common complications in patients undergoing lower abdominal surgery under spinal anesthesia. Redistribution of body heat after neuraxial blockade is the primary cause. Preoperative warming may help prevent these complications by increasing peripheral tissue temperature and reducing the core-to-peripheral gradient.

This prospective randomized clinical study will include 100 ASA 1 to 2 patients aged 18 to 50 years scheduled for elective lower abdominal surgery under subarachnoid block at a tertiary care teaching hospital.

Patients will be randomly divided into 2 groups

Group 1 Active warming Pre-warming with a forced air blanket at 43 degrees Celsius for 20 minutes

Group 2 Control Covered with a double-layered blanket for 20 minutes

Core body temperature will be measured with a tympanic thermometer, and shivering will be assessed using the Crossley and Mahajan scale. Rescue medications IV Tramadol 0.5 mg per kg Ondansetron 0.15 mg per kg will be administered if required.

Primary outcome Incidence of Intraoperative hypothermia

Secondary outcome Incidence and severity of perioperative shivering

The study aims to evaluate whether preoperative warming is effective in maintaining normothermia and reducing shivering during lower abdominal surgeries under spinal anaesthesia.

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 50.00 Year(s)(—)

入选标准

  • 1.Patients undergoing elective lower abdominal surgeries under Subarachnoid block.
  • 2.The American Society of Anesthesiologists Physical Status (ASA-PS) Grade 1 and 2 3.Duration of surgery between 30 minutes to 90 minutes.
  • 4.Age between 18 – 50 years 5.All Genders.

排除标准

  • 1.Patients who are not willing for the study 2.Body mass index (BMI) of more than 30 kg /m2 3.History of convulsions 4.Patient with fever 5.Pre-operative hypothermia 6.Patients having thyroid dysfunction 7.Patients having autonomic neuropathy 8.Patient who requires transfusion of blood and blood products 9.Any Known psychiatric disorders 10.Any Known musculoskeletal disorders 11.Patient on drugs (including alcohol) whose use or withdrawal can cause tremor.
  • 12.External auditory canal pathology – stenosis, growth, ulcers, or any other pathology 13.Failed spinal anaesthesia.

结局指标

主要结局

To determine the effect of preoperative warming on intraoperative hypothermia.

时间窗: Baseline

次要结局

  • To determine the effect of preoperative warming on peri-operative shivering(Baseline)

研究者

发起方
Kodagu Institute of Medical Sciences
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Anushka Rai

Kodagu Institute of Medical Sciences

研究点 (1)

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