Application of Esketamine in Anesthesia of Autism Children Undergoing Colonic Transendoscopic Enteral Tubing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- first movement time
研究概览
简要总结
Autism Spectrum Disorder (ASD) is a group of serious neurodevelopmental disorders. Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. Autistic children have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The investigators intend to explore an optimum anesthetic regimen for autism children undergoing endoscopic procedures.
详细描述
Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. The participants have often been described as difficult to sedate or anesthetize due to a variety of ASD symptoms. It is a challenging task to provide safe and effective sedation during the procedure of colonic TET for FMT in autism children. The primary objective was to compare the clinical efficacy and safety of propofol-esketamine (PE) with propofol-sufentanil (PS) for deep sedation in the procedure of colonic TET in ASD children. A secondary objective was to compare adverse events (AEs) and recovery in those children during/after either PE or PS sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) aged 2-12 years;
- •(2) diagnosed with ASD by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V);
- •(3) evaluated as American Society of Anesthesiologists (ASA) physical status I-II;
- •(4) scheduled for colonic TET procedure.
排除标准
- •(1) oral sedation (premedication) before intravenous catheter placement;
- •(2) any contraindication to study medications;
- •(3) other circumstances in which the investigator determined that a patient was not suitable for participation in the clinical trial.
研究组 & 干预措施
propofol-esketamine
干预措施: propofol combined with esketamine (Drug)
propofol-sufentanil
干预措施: propofol-sufentanil (Drug)
结局指标
主要结局
first movement time
时间窗: Up to 1 hour after the procedure
the time from arriving Postanesthesia care unit to first gross limb movement after procedure
movement score during the procedure
时间窗: through study completion, an average of 10 minutes
(1 = no movement; 2 = semipurposeful allowing continuation of the procedure; 3 = vigorous purposeful movements withholding the procedure)
次要结局
- degree of emergence agitation(Up to 2 hour after the procedure)
- time to full recovery(Up to 3 hour after the procedure)
- arterial blood pressure(through study completion, an average of 15 minutes)
- adverse event(Up to 24 hour after the procedure)