Comparison of inhalational anesthesia (Sevoflurane) and total intravenous anesthesia with propofol, dexmedetomidine on postoperative nausea and vomiting and postoperative recovery parameters in laparoscopic surgery - A prospective randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative nausea & vomiting
研究概览
简要总结
Postoperative nausea and vomiting are common and problematic after general anesthesia in laparoscopic surgery. its incidence as high as 60-80% in high risk patients. Use of opioids and volatile anesthetic agents during maintenance of anesthesia increase the incidence of postoperative nausea and vomiting. So use of alternative agents like propofol and dexmedetomidine during maintenance of anesthesia is effective for prevention of postoperative nausea and vomiting. Postoperative parameters are also variable by using of two different methods during maintenance of anesthesia. So we designed a study to compare the effectiveness of inhalational (sevoflurane) and total intravenous anesthesia with propofol and dexmedetomidine for reduction of postoperative nausea and vomiting and variability in postoperative recovery parameters. All selected patients will be randomized in to two groups (40 patients in each group) depending on the agents used during maintenance of anesthesia. Induction of anesthesia is similar in both groups.
Group A - Anesthesia will be maintained with O2:N2O; 40:60 and sevoflurane to achieve a target BIS between 40 to 60.
Group B- Dexmedetomidine loading dose 1mcg/kg over 15 minutes duration, 5 minutes before induction of anesthesia. Anesthesia will be maintained with dexmedetomidine 0.5mcg/kg/hr and titrated dose of propofol to achieve a target BIS between 40 to 60.
Primary outcome - postoperative nausea and vomiting in first 24 hour postoperative period
Secondary outcome - Postoperative recovery parameter (extubation time, respond to verbal command and orientation time in minutes)
Statistical analysis will be done after completion of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Female
入选标准
- •ASA Grade I and II Scheduled for laparoscopic surgery under general anesthesia.
排除标准
- •Known allergy to study drug.
- •Use of antiemetic drug within 24 hour of surgery.
- •Morbid obesity (BMI >40)
- •Chronic use of opioids.
- •Patient with hepatic , renal and cardiovascular dysfunction.
- •Psychiatric patients.
- •Patient with history of motion sickness.
结局指标
主要结局
Postoperative nausea & vomiting
时间窗: 24 hour postoperative period
次要结局
- 1. Extubation time (minute)(2. Respond to verbal command (minute))
