Co-administration of Ketamine and Propofol for Upper Endoscopy in Children: a Dose-finding Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Dose of Propofol Required to Prevent Movement (Response) to Insertion of Endoscope Into the Patient's Esophagus
研究概览
简要总结
The purpose of this study is to examine the dose-response relationship of ketamine in combination with propofol.
详细描述
Direct visualization of the esophagus, stomach and small intestine is performed using a scope that is inserted while the patient is under under deep sedation or general anesthesia. The most common method of providing general anesthesia for upper endoscopy is intravenous administration of medications such as propofol, often in combination with other medications such as fentanyl, midazolam, remifentanil or ketamine. One study found that the combination of propofol and ketamine provides better conditions (less patient movement, more stable heart and breathing) but more side effects afterwards compared to propofol and fentanyl.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 3-13 years
- •Receiving general anesthesia for upper endoscopy
排除标准
- •Known or possible difficult airway
- •BMI > 35
- •Weight < 10 kg
- •Sedative premedication required
- •Known contraindication to ketamine or propofol
研究组 & 干预措施
Ketamine 0 mg/kg
Ketamine dose will be 0 mg/kg. Propofol dose for the first patient will be 4 mg/kg. Doses for the subsequent patients will increase or decrease by 1.6 mg/kg using the Dixon Up and Down method.
干预措施: Propofol (Drug)
Ketamine 0.25 mg/kg
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
干预措施: Ketamine (Drug)
Ketamine 0.25 mg/kg
Ketamine dose will be 0.25 mg/kg. Propofol dose for the first patient will be 3 mg/kg. Doses for the subsequent patients will increase or decrease by 1.2 mg/kg using the Dixon Up and Down method.
干预措施: Propofol (Drug)
Ketamine 0.5 mg/kg
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/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: Ketamine (Drug)
Ketamine 0.5 mg/kg
Ketamine dose will be 0.5 mg/kg. Propofol dose for the first patient will be 2.5 mg/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)
Ketamine 1.0 mg/kg
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/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: Ketamine (Drug)
Ketamine 1.0 mg/kg
Ketamine dose will be 1.0 mg/kg. Propofol dose for the first patient will be 2 mg/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 Endoscope Into the Patient's Esophagus
时间窗: This outcome is measured at the time of insertion of the endoscope into the esophagus.
The objective is to determine the effective bolus dose in 50% of subjects (ED50) of propofol in combination with ketamine 0, 0.25, 0.5 and 1 mg/kg that produces an adequate depth of anesthesia to prevent minimal or no movement on endoscope insertion in children
次要结局
- Duration of Apnea After Propofol Administration(This outcome will be measured after propofol is administered until the end of the procedure.)
- Incidence of Adverse Respiratory Events During the Procedure(From induction of anesthesia until endoscopy procedure is complete)
- Incidence of Side Effects and Complications During the Recovery Period(From the time procedure is complete until discharge from hospital with an average time of 1 hour.)
研究者
Jason Hayes
Staff Anaesthesiologist
The Hospital for Sick Children