Effects of sugammadex versus neostigmine on postoperative nausea and vomiting after general anesthesia in patients undergoing breast surgery : A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To evaluate the incidence of PONV in patients undergoing reversal with sugammadex versus Neostigmine after general anaesthesia in breast surgery.
研究概览
简要总结
Sugammadex is a selective gamma-cyclodextrin drug that terminates the action of muscle paralysis by encapsulating aminosteroid non-depolarizing muscle relaxant. It is a fast-onset drug without the muscarinic side effects of neostigmine. The well-known side effects of sugammadex were nausea and vomiting but these side effects had been shown to be well-tolerated in adult patients . A meta-analysis involving 17 randomized clinical trials that recruited 1,553 patients were unable to conclusively confirm any evidence for the differences in PONV effects between sugammadex and neostigmine.
Due to these findings, we will be conducting this study with the aim of comparing the PONV effects when neuromuscular blockade was antagonized with sugammadex compared to neostigmine–atropine combination after abdomen surgery in oncological patients undergoing general anaesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Patients willing to participate.
- •2.Patients 18-70 years of age.
- •3.ASA grade 1-4 patients.
- •4.Breast surgery requiring General Anaesthesia.
排除标准
- •1.Patients with history of PONV 2.Impaired renal function 3.Requiring postoperative ventilation 4.Allergic to any study drugs.
结局指标
主要结局
To evaluate the incidence of PONV in patients undergoing reversal with sugammadex versus Neostigmine after general anaesthesia in breast surgery.
时间窗: 8 months.
次要结局
- To asses the postoperative need of anti-emetics and respiratory complications i.e. laryngospasm, bronchospasm & sore throat.(8 months)