Opioid Sparing Anaesthesia Via Dexmedetomidine, Ketamine and Lidocaine Infusion for Prevention of Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgery
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
- The incidence of postoperative nausea and vomiting (PONV)
研究概览
简要总结
In spite of multimodal analgesic strategies, which consist of opioids, dexamethasone, non-steroidal anti-inflammatory drugs, and local anesthetics applied into the surgical wound, postoperative pain and postoperative nausea and vomiting (PONV) are still common complaints reported after laparoscopic gynecological surgery.
So, it is hypothesized that the infusion consisting of lidocaine, dexmedetomidine and ketamine, as an opioid substitute was a feasible technique for laparoscopic gynecological surgery and would be associated with less incidence of PONV and lower opioid requirements in the early postoperative period.
The aim of this study was to evaluate the effect of opioid sparing technique via infusion of Dexmedetomidine, Ketamine and Lidocaine on post-operative nausea and vomiting in laparoscopic gynecological surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective laparoscopic gynaecological surgery, who:
- •had the American Society of Anesthesiologists (ASA) I or II physical status,
- •were 21-60 years of age
排除标准
- •A body mass index >35 kg/ m2
- •Pregnant, breast feeding women
- •Hepatic, renal or cardiac insufficiency
- •Diabetes mellitus
- •History of chronic pain
- •Alcohol or drug abuse
- •Psychiatric disease
- •Allergy or contraindication to any of the study drugs
研究组 & 干预措施
Normal saline (Control) group
A loading infusion of the 50 ml syringe (A) containing normal saline was started at rate of 0.2 ml/ kg/hr ten minutes before induction (as masking for mixture in group S). Then anesthesia was induced with 2 mg/kg ideal body weight (IBW) of propofol , patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (C) containing fentanyl (1 mic/kg of IBW).
干预措施: Normal saline (Drug)
Dexmedetomidine, ketamine and lidocaine (Study) group
A loading infusion of syringe (B) containing the mixture was started at rate of 0.2 ml/kg/h ten minutes before induction. Then anesthesia was induced with 2 mg/kg IBW of propofol, patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (D) containing normal saline (as masking for fentanyl in the control group).
干预措施: Dexmedetomidine, ketamine and lidocaine (Drug)
结局指标
主要结局
The incidence of postoperative nausea and vomiting (PONV)
时间窗: First 24 hours postoperative
The total simplified PONV impact scale score ≥ 5
次要结局
- Intraoperative fentanyl consumption(Intraoperative 3 hours)
- Intraoperative isoflurane consumption(Intraoperative 3 hours)
- Postoperative 24 hours morphine consumption.(First 24 hours postoperative)
研究者
Aya Ibrahim Moustafa
Principal Investigator
Tanta University