Comparison of opioid free anesthesia on postoperative nausea,vomiting and haemodynamic changes after gynaecological laproscopy
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 distressing complaints after general anesthesia in laparoscopic surgery. PONV incidence as high as 60-80% in high risk patients with use of opioids in gynecological laparoscopic surgery. So avoidance of opioids and use of other drugs like dexmedetomidine is another alternative for intraoperative maintenance of anesthesia. Intraoperative hemodynamic changes are also important by use dexmedetomidine in place of opioids. So we designed a study to compare the effectiveness of fentanyl and dexmedetomidine for prevention of postoperative nausea and vomiting and comparison of intraoperative hemodynamic changes (heart rate and blood pressure). All selected patients will be randomized in to two groups (40 patients in each group) depending on the drug given.
Group A - received fentanyl 1.5 mcg/kg, 5 mins before induction of anesthesia
Group B - received dexmedetomidine loading dose 1 mcg/kg over 15 min duration, 5 mins before induction then 0.5 mcg/kg/hr maintenance dose throughout the surgery.
Primary out come - postoperative nausea and vomiting in first 24 hrs postoperative period
Secondary outcome - hemodynamic changes at various intraoperative intervals
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA grade I and II
- •Scheduled for laparoscopic gynecological surgery under general anesthesia.
排除标准
- •1.Known allergy to study drugs 2.Use of antiemetic drugs within 24 hrs of surgery 3.Morbid obesity(BMI>40) 4.Chronic use of opioids 5.Patients with hepatic,renal or cardiovascular dysfunction 6.Psychiatric patients.
结局指标
主要结局
Postoperative nausea & vomiting
时间窗: 24 hour postoperative period
次要结局
- Hemodynamic changes heart rate systolic blood pressure diastolic blood pressure mean blood pressure(Preoperative period, after study drug, after induction, after intubation, after pneumoperitoneum at 15 min intervals, post pneumoperitoneum, after surgery, after extubation)