To evaluate the effect of early versus late paracetamol administration on postoperative shivering and pain scores after general anaesthesia- A prospective randomized double blind clinical study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- To compare the proportion of patients developing postoperative shivering till 4 hours postoperatively after intraoperative administration of early and late paracetamol.
研究概览
简要总结
This is a double blind randomized controlled study to evaluate the effect of early and late paracetamol administration on postoperative shivering (POS) and pain scores.
A total of 174 patients will be studied. Eligible participants will be randomly allocated to one of the two groups:
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Early PCM group- who will receive IV PCM 15 mg/kg (maximum 1 g) over 20 min immediately after anaesthesia induction.
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Late PCM group- who will receive IV PCM 15 mg/kg (maximum 1 g) for 20 min approximately 30 min before completion of surgery.
The primary outcome will be to compare the proportion of patients developing POS till 4 hours postoperatively after intraoperative administration of early and late paracetamol.The secondary outcomes are
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To assess and compare the severity of shivering in patients developing POS.
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To observe the pain scores and time to analgesic requirement in the postoperative period with early and late PCM administration while minimizing the effect of intraoperative opioids on postoperative pain scores.
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To compare the proportion of patients developing postoperative hypothermia after early and late PCM administration while maintaining intraoperative normothermia.
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
- •1.Patients scheduled for elective surgery under general anesthesia 2.Age 18-65 years 3.Either gender 4.American Society of Anaesthesiologists (ASA) physical status classification system I/II 5.Expected duration of surgery 1- 4 h.
排除标准
- •1.Patient refusal 2.BMI more than 40 kg/cm2
- •Known allergy to paracetamol or contraindications to its use 4.Pre-operative and intraoperative body temperature more than 38°C or less than 36°C 5.Patients having history of seizures, thyroid or hepatic disorder.
结局指标
主要结局
To compare the proportion of patients developing postoperative shivering till 4 hours postoperatively after intraoperative administration of early and late paracetamol.
时间窗: Just after shifting patient to post-anaesthesia care unit, then at every 30 mins till 4 hours postoperatively
次要结局
- 1. To assess and compare the severity of shivering in patients developing POS.(2. To observe the pain scores and time to analgesic requirement in the postoperative period)
研究者
Dr Shiny Sharon
AIl India Institute of Medical Sciences, Rajkot, Gujarat