NCT01519154已完成3 期
Untersuchung Unterschiedlicher Sedationstechniken für Elektive Magnetresonanztomographie (MRT)-Diagnostik Bei Kindern Anhand Klinischer Und MRT-basierter Outcomeparameter (Propofol Versus Propofol-Ketamin)
Achim Schmitz1 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2018年2月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
Children < 10 years of age often need deep sedation or anaesthesia to allow elective diagnostic magnetic resonance imaging; standard routine protocols are
- propofol induction without other sedative (Propofol much as needed) or hypnotic drugs and propofol infusion 10 mg/kg h
- propofol induction with ketamine 1 mg /kg (little repetitive Propofol doses as needed) and propofol infusion 5 mg / kg h
both protocols are compared with regard to clinical outcome and, in cases with cerebral MRI, cerebral perfusion/blood flow.
Hypothesis:
- reduces recovery time compared to propofol mono sedation
- combination of ketamine-propofol increases incidence of Postoperative nausea and vomiting (PONV) compared to propofol mono sedation
- combination of ketamine-propofol increases global cerebral blood flow and changes regional distribution of cerebral perfusion compared to propofol mono 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MRT in deep sedation
- •outpatient
- •> 3 months to <= 10 years
排除标准
- •tracheal intubation required
- •contraindication of ketamine or propofol
- •additional painful procedure requiring analgesics
研究组 & 干预措施
Propofol
Active Comparator
Propofol 10 mg/h as maintenance infusion
干预措施: Propofol (Drug)
Ketamine-Propofol
Experimental
Additional Ketamine at induction, Propofol 5 mg/h as maintenance infusion
干预措施: Ketamine-Propofol (Drug)
结局指标
主要结局
Recovery time
时间窗: 1 - 3 hours post anaesthesia
Time from end of MRI until recovery defined as Aldrete Score = 10
次要结局
- Incidence of emergence delirium(1 - 4 hours post anaesthesia)
- Quality of sedation(during MRI, on the average 45 minutes)
- respiratory and cardiovascular adverse events(during sedation, on the average 60 minutes)
- Demission time(1 - 4 hours post anaesthesia)
- PONV(24 hours)
- Cerebral perfusion(first 10 minutes of MRI)
研究者
Achim Schmitz
Principal Investigator
University Children's Hospital, Zurich
研究点 (1)
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