Comparison of Emergence Agitation in Children Following Tonsillectomy and Adenoidectomy Under Remimazolam or Sevoflurane General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- The incidence of emergence delirium
研究概览
简要总结
Emergence delirium can lead to a range of clinical problems and is even associated with short-term behavioral changes in children. Pediatric ear, nose, and throat (ENT) surgery is one of the most common surgical types for postoperative delirium in children. Sevoflurane anesthesia is also a known cause of postoperative delirium. Therefore, this study aims to explore whether there is a difference in the incidence of postoperative delirium in children under remimazolam general anesthesia and sevoflurane anesthesia.
详细描述
children aged 3-6 years old were randomly and equally allocated into two groups: Group R remimazolam, Group S with sevoflurane, respectively.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-6 years;
- •American Society of Anaesthesiologist (ASA) I or II;
- •Booked for Tonsillectomy and Adenoidectomy;
- •BMI for age between the 25th and 85th percentiles according to the 2000 Centers for Disease Control and Prevention (CDC) growth charts.
排除标准
- •Children (ASA III- IV) who had abnormal liver and kidney function, cardiovascular, endocrine dysfunction, or any other organ dysfunction;
- •Allergy or hypersensitive reaction to remimazolam;
- •mental disorder
- •Recently respiratory infection;
- •Other reasons that researchers hold it is not appropriate to participate in this trial: under specialized care or lived in social welfare institutions, or any other factors that could affect their ability to participate in the study.
研究组 & 干预措施
Group R
Induction of anesthesia:Anesthesia will induced with remimazolam at 0.3-0.5 mg/kg; Maintenance of anaesthesia:Remimazolam will infuse initially at a rate of 2 mg/kg/h (1-3 mg/kg/h).
干预措施: Remimazolam (Drug)
Group S
Induction of anesthesia:Anesthesia will induced with 8% sevoflurane in 100% oxygen at flow rate of 6 L/min; Maintenance of anaesthesia:Anesthesia depth was maintained at 1-1.5 MAC by sevoflurane.
干预措施: Sevoflurane (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
- Extubation time(Within up to 30 minutes after operation)
- Recovery times(Within up to 30 minutes after operation)
- PHBQ-AS(3 days after operation)
- Number of children with adverse effects(Up to 24 hours including intraoperative, and postoperative periods)
- The Face, Legs, Activity, Cry, Consolability Scale (FLACC)(Within up to 30 minutes after operation)
- Pediatric anesthesia emergence delirium(Within up to 30 minutes after operation)