Determination of the Median Effective Dose of Propofol in Combination With Different Doses of Esketamine During Colonoscopy for Children With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1
研究概览
简要总结
The purpose of this study is to examine the dose-response relationship of esketamine in combination with propofol for children with Autism Spectrum Disorder undering colonoscopy.
详细描述
Autistic children appear with significant frequency for medical services, lots of which requiring procedural sedation or anaesthesia. They 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 colonoscopic procedure in autism children. Propofol sedation for endoscopic procedures is safe and acceptable for children, especially those who express significant anxiety. Propofol-based sedation turned out to be the most effective dosage regimens, with effectiveness comparable to general anesthesia. The addition of certain dose ketamine to propofol may increase the effectiveness without creating more adverse events.
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
- Single (Participant)
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 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
eskatemine 0.3mg/kg + propofol
eskatemine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
干预措施: Esketamine (Drug)
eskatemine 0.3mg/kg + propofol
eskatemine dose will be 0.3 mg/kg. Propofol dose for the first patient will be 2.5mg/kg. Doses for the subsequent patients will increase or decrease by 0.8 mg/kg using the Dixon Up and Down method.
干预措施: Propofol (Drug)
eskatemine 0.6mg/kg + propofol
eskatemine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
干预措施: Esketamine (Drug)
eskatemine 0.6mg/kg + propofol
eskatemine dose will be 0.6 mg/kg. Propofol dose for the first patient will be 2.0mg/kg. Doses for the subsequent patients will increase or decrease by 0.4 mg/kg using the Dixon Up and Down method.
干预措施: Propofol (Drug)
结局指标
主要结局
Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 1
时间窗: Procedure (This outcome is measured at the time of insertion of colonoscopy)
The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.
Dose of Propofol Required to Prevent Movement (Response) to Insertion of colonoscpopy 2
时间窗: Procedure (This outcome is measured at the time of insertion of colonoscopy)
The objective is to determine the effective bolus dose in 95% of subjects (ED50) of propofol in combination with ketamine 0.3, 0.6mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on colonoscopy insertion in children with Autism spectrum disorder.
次要结局
- movement score during the procedure(during the procudure)
- adverse event(during the procedure - 24 hours after procedure)
- arterial blood pressure(during the procudure)