The Effect of Remimazolam on Emergence Delirium in Pediatrics Undergoing Neurosurgery With Sevoflurane Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Emergence delirium
研究概览
简要总结
Emergence delirium is a common complication in pediatrics undergoing neurosurgery. Previous study showed that a single bolus of remimazolam was associated with lower incidence of postoperative agitation. Present study was designed to investigate if remimazolam supplemented to sevoflurane anesthesia could decrease the risk of emergence delirium in pediatrics undergoing neurosurgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1 to 6 years old
- •Planned to receive elective neurosurgery under general anesthesia
- •Expected duration of surgery > 1 hour
排除标准
- •Allergy to benzodiazepine
- •Use of other sedatives within 12 hours before surgery such as benzodiazepines, propofol, chloral hydrate, etc.,
- •ASA classification IV or above
- •Unable to complete emergence delirium assessment, such as language, hearing or vision impairment.
研究组 & 干预措施
Remimazolam group
A loading dose of remimazolam 0.3 mg/Kg was given at anesthesia induction and followed with 1 mg/Kg/h until 10 minutes before the end of surgery. Sevoflurane was used to maintain BIS between 40-60.
干预措施: Remimazolam (Drug)
Normal saline group
An identical volume of normal saline was given as placebo. Patients received sevoflurane to maintain anesthesia depth (BIS) 40-60
干预措施: Normal Saline (Drug)
结局指标
主要结局
Emergence delirium
时间窗: The subjects were evaluated at 10 minutes, 20 minutes, 30 minutes after admission to PACU or before discharge
The Cornell Assessment of Pediatric Delirium (CAPD) was used to assess delirium. It consists of a total of 8 items, with each item scored from 0 to 4. Delirium can be diagnosed when the total score is ≥ 10.
次要结局
- Sleep quality within 3 days after surgery(Within 3 days after surgery)
- Postoperative delirium(Delirium was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery)
- Pain score(Pain intensity was assessed at 07:00~09:00 and 17:00~20:00 on the 1st, 2nd and 3rd day after surgery)
- Sleep quality 7 days after surgery and 1 month after surgery(7 days after surgery and 1 month after surgery)
- Postoperative adverse behavior change(1st, 3rd days after surgery)
研究者
Mu Dong Liang
Professor
Peking University First Hospital