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临床试验/CTRI/2019/02/017541
CTRI/2019/02/017541招募中不适用

Comparative evaluation of preoperative paracetamol and a combination of paracetamol with nebulised or intravenous dexamethasone for prevention of postoperative sore throat

Safdarjung Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年2月15日最近更新:

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.)

研究者

申办方类型
Government medical college

研究点 (1)

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