Comparing Safety and Efficacy of Dexmedetomidine and Propofol in Patients Requiring Sedation for MRI Scanning
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Adverse Events During the Sedation and Recovery Period
研究概览
简要总结
This is a prospective, open label randomized study. The purpose of this study is to compare propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically identifying important patient demographics and looking at important outcomes including adverse events.
详细描述
Patients will be randomized to either arm of the study. Throughout the sedation and recovery period, all study patients will have careful, routine documentation of hemodynamics (blood pressure, heart rate, plus oximeter, respiratory rate) as well as sedation depth. Patients will remain in recovery room until they have maintained discharge criteria for 30 minutes.
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
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is 3 - 11 years
- •Patient is scheduled for MRI at Children's Hospital Boston.
- •Patient meets criteria to receive either dexmedetomidine or propofol sedation
- •Patient's guardian provides written consent
排除标准
- •Patient does not meet established sedation criteria
- •Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
- •Patient has current, repaired, or risk for Moya-Moya disease
- •Patient has had a stroke within the past six months
- •Patient has uncontrolled hypertension
- •Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
- •Known soy, Lecithin, or egg allergy
研究组 & 干预措施
Dexmedetomidine Group
Dexmedetomidine given as 2mcg/kg bolus over 10 minutes followed by 1.5mcg/kg/hr infusion for duration of scan. The bolus may be repeated up to 2 times at any time during the sedation in the event that adequate sedation conditions (minimum Ramsay Sedation Score of 4) are not achieved. In the event that dexmedetomidine is unable to achieve motionless conditions, after a total of 3 boluses, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg, per established protocol.
干预措施: Dexmedetomidine (Drug)
Propofol Group
Propofol bolus at an initial dose of 1 mg/kg over 1 minute then up to two additional 1 mg/kg boluses may be administered (total 3 mg/kg) - each over a one (1) minute interval, waiting 30 seconds after completion of each bolus to reassess sedation level. Once a minimum Ramsey Sedation Score 4 is achieved, an infusion at 125 mcg/kg/min is initiated. It may be titrated to 300 mcg/kg/min. If there is movement or awakening the patient may be rebolused with no more than 2 doses of Propofol at 1 mg/kg over 1 minute, in the same dosing manner as described above, waiting 30 seconds between doses. If adequate sedation is not achieved, 0.5 mg/kg IV pentobarbital may be administered at q1 minute intervals up to a maximum of 2 mg/kg.
干预措施: Propofol (Drug)
结局指标
主要结局
Number of Adverse Events During the Sedation and Recovery Period
时间窗: During sedation, recovery period and overnight, up to 24 hours
Adverse events will be described by type, system involvement and level of severity.
次要结局
- Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations)(During sedation, recovery and overnight, up to 24 hours)
研究者
Randy Prescilla
Assistant in Perioperative Anesthesia
Boston Children's Hospital