Ciprofol Based on Total Intravenous Anesthesia During Pediatric Laparoscopic Surgery: a Prospective, Double-blind, Randomized Controlled, Non Inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Extubation time
研究概览
简要总结
a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of total intravenous anesthesia in pediatric laparoscopic surgery.
详细描述
Ciprofol is a better alternative to surgical sedatives. The clinical application basis of Ciprofol in pediatric anesthesia is still lacking. Therefore, the investigators designed a prospective, double-blind, fully randomized controlled, non-inferiority clinical trial to investigate the use of all-through intravenous anesthesia in pediatric laparoscopic surgery. Our main hypothesis is that in pediatric surgery, using Ciprofol by intravenous anesthesia, the extubation time is no longer than that the propofol group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •laparoscopic surgery under general anesthesia
排除标准
- •Known allergies to propofol and ciprofol,
- •Mental retardation, cognitive and affective disorders, psychiatric or neurological disorders;
- •uncooperate with peripheral venipuncture and catheterization;
- •History of acute upper respiratory tract infection in the past 2 weeks;
- •With severe respiratory, circulation, liver and kidney insufficiency;
- •Body mass index (BMI) of 30 kg/m² or 15 kg/m²;
- •Known long-term use of sedative drugs;
- •ASAⅢ grade or above;
- •recent participation in other clinical studies.
研究组 & 干预措施
Ciprofol
Ciprofol for anesthesia induction (0.5mg / kg) and anesthesia maintenance (1-2.5mg/ (kg·h))
干预措施: Ciprofol (Drug)
Propofol
Propofol for anesthesia induction (2mg / kg) and maintenance of anesthesia (4-10 mg / (kg·h))
干预措施: Propofol (Drug)
结局指标
主要结局
Extubation time
时间窗: up to 1 hour
Time interval between drug withdrawal and removal of the tracheal catheter
次要结局
- Aldrete Score(up to 2 hours)
- Emergence Agitation(up to 2 hours)
- Postoperative Pain(24 hours)
- Postoperative nausea and vomiting(24 hours)
- satisfaction degree(24 hours)