Comparative evaluation of preoperative paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone for prevention of postoperative sore throat
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To compare the incidence of postoperative sore throat in patients receiving preoperative intravenous paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone
研究概览
简要总结
Postoperative sore throat (POST) is a common complication following general anaesthesia which is distressing to the patient. Dexamethasone is a corticosteroid with potent analgesic, anti-inflammatory and antiemetic action. Paracetamol is an effective analgesic and antipyretic agent commonly used for intraoperative and postoperative analgesia. The present study plans to evaluate the effect of preoperative administration of paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone for prevention of postoperative sore throat. The study hypothesis is that a combination of intravenous paracetamol with nebulised or intravenous dexamethasone is superior to intravenous preoperative paracetamol alone in decreasing the incidence of postoperative sore throat in adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia with tracheal intubation. The aim of this study is to evaluate the effect of preoperative administration of paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone for prevention of postoperative sore throat, hoarseness of voice and cough in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia with tracheal intubation. Patients will be randomised into one of the three study groups ( 50 patients in each group)with the help of computer generated random number table in blocks of ten.
Group P: Patients will receive nebulised normal saline (5 ml) + IV normal saline (5ml) + IV paracetamol 1g infusion. Group I: Patients will receive nebulised normal saline (5 ml) + IV dexamethasone 8mg (5ml) + IV paracetamol 1g infusion. Group N: Patients will receive nebulised dexamethasone 8mg (5ml) + IV Normal saline (5ml) + IV Paracetamol 1g infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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 fulfilling the criteria of American Society of Anesthesiologists Physical Status I and II adults
- •scheduled for elective laparoscopic cholecystectomy under general anaesthesia with tracheal intubation.
- •Either gender, aged 18-65 years.
排除标准
- •Patients with a history of recent respiratory tract infection or sore throat within <2 weeks
- •Patients with anticipated difficult intubation
- •Patients receiving analgesic or steroid therapy or known allergy to study drugs
- •Patients with diabetes, obesity, cardiac, respiratory, hepatic or renal disease
- •Pregnant women
- •Surgery duration greater than 3 hours.
结局指标
主要结局
To compare the incidence of postoperative sore throat in patients receiving preoperative intravenous paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone
时间窗: At recovery 0,1, 6, 12 and 24 hours postoperatively
次要结局
- 1. To compare the severity of postoperative sore throat among the three groups.(2. To compare the incidence of hoarseness of voice and cough among the groups.)
