Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Verbal Descriptive Scale
研究概览
简要总结
Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting.
It has been suggest that antagonism of residual neuromuscular block with a mixture of neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea and vomiting.
Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse effects include slight coughing, movement, an altered taste sensation in the mouth, transient prolongation of the QT interval, hypersensitivity, and a short term prolongation of the activated partial thromboplastin time.
The aim of this study was to compare the sugammadex versus neostigmine plus atropine for reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative nausea and vomiting.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status 1 and 2
- •endotracheal intubation and general anesthesia scheduled for elective surgery
排除标准
- •age < 18 years, > 65 years
- •pregnancy
- •refusal to participate and patients already participating in another study
- •allergy to study drugs
- •communication difficulty
- •psychiatric and neurological disorders
- •use of analgesics or sedative or antiemetic drugs within 24 hours before surgery.
- •emergency surgery
- •history of drug or alcohol abuse
- •ASA 3 and above
- •patients with vertigo
- •Laparoscopic surgery, oncologic surgery, strabismus and mid ear surgery neurosurgery, gynecologic surgery, breast surgery
研究组 & 干预措施
neostigmine
干预措施: Neostigmine (Drug)
sugammadex
干预措施: sugammadex (Drug)
结局指标
主要结局
Verbal Descriptive Scale
时间窗: within postoperative 24 hours
0: no nausea 1: mild 2: moderate 3: severe
次要结局
未报告次要终点
研究者
özgür yağan
MD
T.C. ORDU ÜNİVERSİTESİ