Comparative Study Of The Effects Of Preoperative Carbohydrate Drink On Postoperative Nausea And Vomiting In Patients Undergoing Elective Laparoscopic Cholecystectomy Under General Anaesthesia - A Randomized Double Blinded Placebo-Controlled Study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To study the effect of administration of preoperative carbohydrate drink on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
研究概览
简要总结
Postoperative nausea and vomiting is a common and distressing complication after anaesthesia and surgery with an incidence of approximately 30%. Although postoperative nausea and vomiting is self- limiting and non fatal, it is unpleasant and is a greater concern than postoperative pain. Preoperative carbohydrate drink has shown to reduce the risk of postoperative nausea and vomiting and helps in improving the preoperative patient comfort. Although this concept of preoperative carbohydrate drink is being used, there are not many studies in which preoperative carbohydrate drink is used to prevent postoperative nausea and vomiting and preoperative comfort, hence we are planning to conduct a clinical study on this.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA Grade I and II patients posted for elective laparoscopic cholecystectomy with a duration of surgery within 3 hours 2)Non smoker 3)No history of postoperative nausea and vomiting 4)No history of emetic episode in the last 24 hours.
排除标准
- •Patients with Diabetes mellitus and patients of ASA Grade III and above 2)Patients with Gastro-oesophageal reflux disease, delayed gastric emptying 3)Patients on pharmacological treatment that impairs gastrointestinal motility 4)Patients who are on treatment with Antipsychotics and steroids 5)Difficult airway 6)History of motion sickness 7)BMI more than 30 kg per meter square 8)Pregnancy.
结局指标
主要结局
To study the effect of administration of preoperative carbohydrate drink on postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
时间窗: Post operatively at 0 to 4 hours, 4 to 12 hours and 12 to 24 hours
次要结局
- To study the effect of preoperative carbohydrate drink on preoperative well being (where fatigue and irritability will be assessed).(Pre operatively (10 minutes before shifting to OT))
研究者
Dr Bharath V
BGS Global Institute of Medical Sciences