Comparision of intraperitoneal dexamethasone, dexmedetomidine and dexamethasone-dexmedetomidine combination on postoperative nausea and vomiting and analgesics requirement after gynecological laparoscopy: a randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Incidence of post operative nausea and vomiting
研究概览
简要总结
Postoperative nausea and vomiting is common, but distressing complaint following general anesthesia. The PONV incidence as high as 60% to 80% in high risk patients when no prophylactic antiemetics used.
In this modern era of surgery intraperitoneal instillation of drugs has become an important method to control postoperative nausea and vomiting and decrease the analgesic requirement. Intraperitoneal dexamethasone and dexmedetomidine has been used separately for prevention of PONV. However, there is no study to compare the effectiveness of these drugs alone or in combination for prevention of PONV and analgesic requirement via intraperitoneal route.
All selected patients will be randomized in to 4 groups (40 in each group) depending on the drug given
Group D1 - received dexamethasone 8 mg intraperitoneally at the end of the procedure, before laparoscopic trocar withdrawal, in total volume of 20 ml
Group D2 - received dexmedetomidine 1 mcg/kg intraperitoneally at same time and same volume
Group D3 - received dexamethasone 8 mg and dexmedetomidine 1 mcg/kg at the same time and same volume
Group D4 - receive 20 ml normal saline at the same time
Primary outcome - incidence of post operative nausea and vomiting
Secondary outcome - Total paracetamol requirement in 24 hr post operative period
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
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA grade I and II
- •Scheduled for laparoscopic gynaecological surgery under general anesthesia.
排除标准
- •1.Known allergy to study drugs 2.Use of antiemetic drugs within 24 hours of surgery 3.Morbid obesity( body mass index>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
Incidence of post operative nausea and vomiting
时间窗: 24 hr postoperatve period
次要结局
- Total consumption of paracetamol(24 hr postoperative period)