Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia: a Double-blinded Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The incidence of emergence delirium
研究概览
简要总结
Emergence delirium (ED) is a manifestation of acute postoperative brain dysfunction that occurs with a relatively high frequency after pediatric anesthesia. The incidence varies depending on the diagnostic criteria used and the combination of administered anesthetic drugs. The use of sevoflurane has been identified as one of the most important risk factors. In the investigators' study，the researchers conducted the current study to investigate whether remimazolam can reduce incidence of ED.
详细描述
One hundred twenty children aged 1-6 years old were randomly allocated into three equal groups. Anesthesia is induced with propofol，fentanyl and rocuronium. In group P (Placebo group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. In group B (Bolus group), anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered. In group C (continuous infusion group), anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered. Maintain BIS values in the range of 40-60. Recorded the pediatric anesthesia emergence delirium scale (PAED) during the recovery period.
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
- 是
入选标准
- •with American Society of Anesthesiologists (ASA) physical status I or II；
- •aged 1-6 years；
- •children with weight for age within the normal range；
- •were scheduled laparoscopic surgery by sevoflurane anesthesia.
排除标准
- •children who had Abnormal liver and kidney function,Cardiovascular or endocrine dysfunction;
- •allergy or hypersensitive reaction to remimazolam;
- •with any organ dysfunction;
- •recently respiratory infection, mental disorder;
- •other reasons that researchers hold it is not appropriate to participate in this trial.
研究组 & 干预措施
group P (Placebo group)
Patients were assigned to group P (Placebo group) using a computer-generated random number table
干预措施: normal saline (Other)
group B (Bolus group)
Patients were assigned to group B (Bolus group) using a computer-generated random number table
干预措施: Bolus Remimazolam (Drug)
group C (continuous infusion group)
Patients were assigned to group C (continuous infusion group) using a computer-generated random number table
干预措施: Continuous Infusion Remimazolam (Drug)
结局指标
主要结局
The incidence of emergence delirium
时间窗: Within up to 30 minutes after operation
The pediatric anesthesia emergence delirium scale consists of four items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score.pediatric anesthesia emergence delirium scale ≥10 at any time indicates presence of emergence delirium.
次要结局
- FLACC scale(Within up to 30 minutes after operation)
- Pediatric anesthesia emergence delirium(Within up to 30 minutes after operation)
- Number of children with adverse effects(Up to 24 hours including intraoperative, and postoperative periods)
- End tidal sevoflurane concentration(During the preoperative period)
- Recovery times(Up to 30 minutes after operation)
- Ramsay Sedation Scale score(Within up to 30 minutes after operation)