NCT00515359已完成不适用
RCT for Intermittent Versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 276
- 试验地点
- 2
- 主要终点
- to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing
研究概览
简要总结
RCT for Intermittent versus Continuous Propofol Sedation for Pediatric Brain and Spine MRI Studies
详细描述
A study comparing the dose of propofol used as a continuous infusion versus intermittent bolus dosing looking at recovery time complications, and quality of the MRI studies in Pediatric Sedation Services for patients age 1 month to 18 years receiving an brain or spine MRI.
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
- None
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1 month to 18 years
- •Receiving a brain or spine MRI with propofol sedation
- •Deemed safe to undergo sedation with propofol based on a pre-sedation examination
- •Patient judged not to require any pre-medication with any other medication except nasal decongestants or anticholinergic medications
排除标准
- •Patient below or above set age limits.
- •Patient requires MRI studies on other body areas.
- •Patient requires pre-medication with a sedative or tranquilizer
- •Patient requires additional medications during sedation to complete the procedure.
- •Propofol is being used as a rescue sedative to complete the procedure.
- •Propofol is being used as a rescue sedative to complete a procedure that was initiated by another sedative.
- •Patients who develop complications that require termination of the imaging procedure will not be included in the dose or recovery time calculations, but the complication will be counted as such in their respective group and study will be reported as non-diagnostic.
- •Insulin dependent diabetes
- •Thyroid disease
结局指标
主要结局
to compare recovery time, complications and quality of the MRI studies when continuous infusion of propofol was used versus intermittent bolus dosing
时间窗: study completion
次要结局
未报告次要终点
研究者
研究点 (2)
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