The Effect of Penehyclidine on Postoperative Nausea and Vomiting After Strabismus Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Incidence of PONV
研究概览
简要总结
Patients scheduled for elective strabismus surgery under general anesthesia in the First Affiliated Hospital of Nanjing Medical University will be included in this study.
Patients 1)ASA I or II, 2)aged 3-65 years, 3)scheduled for elective strabismus surgery under general anesthesia, will be included in the study. Patients 1)had prior PONV, 2)severe motion sickness, 3)a history of ophthalmic surgery, 4)had received drugs known to have antiemetic effects, will be excluded from the study.
The primary aim is to evaluate the prophylaxis effect of penehyclidine(a novel long acting selective anticholinergic agent developed in China) on postoperative nausea and vomiting after strabismus surgery. Secondary outcomes include the effect of PONV risk factors and surgical technique on PONV rank score, occurance of oculocardiac reflex, time to extubation.
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, Investigator)
入排标准
- 年龄范围
- 3 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II
- •Aged 3-65 years
- •Scheduled for elective strabismus surgery under general anesthesia
排除标准
- •Had prior PONV
- •Severe motion sickness
- •A history of ophthalmic surgery
- •Had received drugs known to have antiemetic effects in 24h before surgery
研究组 & 干预措施
Penehyclidine
Patients in this arm will receive penehyclidine after anesthesia intubation.
干预措施: Penehyclidine (Drug)
Normal Saline
Patients in this arm will receive normal saline after anesthesia intubation.
干预措施: normal saline (Drug)
结局指标
主要结局
Incidence of PONV
时间窗: From extubation to 48 hours after surgery
Occurance of postoperative nausea and vomiting after strabismus surgery
次要结局
未报告次要终点