Impact of intraoperative timing and administration of paracetamol on postoperative shivering : A randomised double blind controlled trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- The incidence of shivering.
研究概览
简要总结
Following general anesthesia, postoperative shivering is common. The mechanism may be thermogenic or non-thermogenic. During the postoperative phase, there is an increase in the set point for core body temperature, which is reached by shivering. Numerous adverse effects, including an increased risk of hypoxemia and surgical complications, may result from this. In addition to having an anti-shivering action, paracetamol can worsen intraoperative hypothermia.
This study compares the incidence of shivering as the primary outcome and the incidence of perioperative hypothermia (temperature less than 36°C) and the time to the analgesic requirement as secondary outcomes when paracetamol was administered after induction of anaesthesia or towards the conclusion of surgery.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA physical status I/II adult patients of either gender undergoing elective surgical procedures performed under General Anaesthesia.
- •Expected duration of surgery between 1 and 4 h.
排除标准
- •Surgeries more than 4 hour duration.
- •Those having body mass index more than 35 kg/m
- •Evidence of liver dysfunction.
- •History of allergy to Paracetamol.
- •Body temperature more than 38°C or less than 36°C.
结局指标
主要结局
The incidence of shivering.
时间窗: The incidence of shivering will be assessed every 30 minutes postoperatively up to a period of 4 hours.
次要结局
- The incidence of perioperative hypothermia (temperature less than 36°C)(Core temperature will be monitored every 15 minutes after induction of anaesthesia till the completion of surgery & every 30 minutes after completion of surgery up to a period of 4 hours.)
- Time to analgesic requirement postoperatively(Pain & time to analgesic requirement will be monitored every 30 minutes after surgery upto a period of 4 hours.)
研究者
Norin Qashifa
Sri Ramachandra Institute of Higher Education and Research