Caffeine Facilitates the Recovery of Dexmedetomidine Sedation for MRI in Pediatric Patients: a Randomized, Double-blinded and Placebo-controlled Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improve rate of wakefulness post surgery
研究概览
简要总结
Dexmedetomidine (Dex), a selective α2-adrenergic receptor agonist, is the most used sedative for procedural sedation in children and in pediatric Intensive Care Unit (PICU) because it is associated with less respiratory depression and also less neurotoxicity; rather Dex appears neuroprotective. Unfortunately, Dex is associated with very long emergence times and may cause bradycardia and hypotension. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. With this Dex sedation protocol, these pediatric patients usually take an average of 45 minutes (30-60 minutes) to wake and become alert and up to 2 hours to be discharged.
Without reversal agents, emergence times from Dex sedation are slow. The prolonged recovery after Dex sedation for non-surgical procedures negatively affects throughput, thus increasing the cost of care. Patient safety and satisfaction suffer as a result. The children wake feeling tired and sluggish. The children don't feel back to normal for an extended period of time, which is not surprising given that the half-life for Dex metabolism in 2-3 hours in humans. However, using sedation dosing guidelines (by consensus among SPS members) 1-3 mcg/kg bolus and a 1-2 mcg/kg/hour infusion, hemodynamic compromise is less significant and rarely requires intervention in these patients. In humans, it has been found that caffeine at 7.5 mg/kg (15 mg caffeine citrate equivalent to 7.5 mg caffeine base) sped emergence from isoflurane anesthesia with minimal hemodynamic effects in healthy human volunteers.
The goal of this clinical trial is to determine whether caffeine will facilitate the recovery of Dex sedation after a Magnetic Resonance Imaging (MRI) procedure by measuring the time from the end of Dex infusion to the time meeting the discharge criteria.
详细描述
SCREENING DAY (-1-3) - PRIOR TO APPOINTMENT Only a single visit will take place prior to the MRI scan procedure. This will be done one to three days prior to the sedation procedure, via chart screening or on the day of the sedation and MRI procedure if the advanced review is not possible.
Once potentially appropriate subjects have been identified from the OR schedule for the next day, the study team will contact the anesthesia provider (resident, CRNA, attending) who is scheduled to treat that patient and explain to him/her about the research project and ask them to use a Sedline Brain Function Monitor for the case.
- Sedation team calls patient family with reminder about appointment and NPO instructions.
- Research pharmacy notified about potential patients.
DAY 0 - APPOINTMENT DAY On the day of the Magnetic Resonance Imaging (MRI) procedure in the preoperative holding area.
- Study consent or/and assent obtained by study team in the pre-sedation area.
- Study team notifies research pharmacy to prepare/deliver study drug
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, Investigator)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergo Magnetic Resonance Imaging (MRI) scan
- •Age ≥3 and ≤ 12 yr old
- •Both Male and Female
- •Weight ≤33.3 kg
- •American Society of Anesthesiologists ASA) physical status 1-3
- •No History of Arrhythmia (3-leads Electrocardiogram [EKG] applied before and after the sedation) or congenital heart disease
- •Capable of obtaining consent from at least one parent
- •No history of liver and kidney impairment
- •No history of head trauma
- •No prior history of difficulty with anesthesia
- •No personal or family history of malignant hyperthermia
排除标准
- •Age <3 or >12
- •Weight >33.3 kg
- •ASA physical status > 3
- •History Arrhythmia, congenital heart disease, liver, and kidney diseases
- •Prior difficulty with anesthesia
- •Personal or family history of malignant hyperthermia
- •Unable to obtain consent
- •History of head trauma
- •Female subjects who are pregnant
研究组 & 干预措施
Dexmedetomidine +/- Caffeine Sedation
Eligible subjects will be given 15 mg/kg caffeine citrate (equivalent to ~5 mg/ kg caffeine base) ~ 15 min after terminating Dex's infusion.
干预措施: Caffeine citrate 15mg/kg (Drug)
Dexmedetomidine +/- Placebo Sedation
Eligible subjects will be given 9 mg/ml saline placebo) ~ 15 min after terminating Dex's infusion.
干预措施: 0.9% Sodium Citrate (Drug)
结局指标
主要结局
Improve rate of wakefulness post surgery
时间窗: Up to 2 hours
Subject post-surgery wakefulness recovery with caffeine based on a modified Aldrete score
次要结局
- Time needed to be able to return to tasks performance with purpose(Up to 2 hours)