Caffeine Facilitates the Recovery of Dexmedetomidine Sedation for MRI in Pediatric Patients: a Randomized, Double-blinded and Placebo-controlled Pilot Study
University of Chicago
Summary
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.
Description
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 Functi…
Eligibility
- Age range
- 3–12 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Exclusion Criteria: * Age \<3 or \…
Interventions
- DrugCaffeine citrate 15mg/kg
Subjects will be randomized prior to surgery into one of the two study arms. One arm will receive 15mg/kg Caffeine citrate 15 minutes post surgery.
- Drug0.9% Sodium Citrate
Subjects will be randomized prior to surgery into one of the two study arms. One arm will receive 0.9% Sodium Citrate/kg 15 minutes post surgery.
Location
- University of Chicago Medical CenterChicago, Illinois