Caffeine Facilitates the Recovery of Dexmedetomidine Sedation for MRI in Pediatric Patients: a Randomized, Double-blinded and Placebo-controlled Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 12
Healthy Volunteers: t
View:

• 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

Locations
United States
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Contact Information
Primary
Zheng Xie, MD, PhD
jxie@bsd.uchicago.edu
773-702-2667
Time Frame
Start Date: 2024-09-09
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
Experimental: 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.
Placebo_comparator: Dexmedetomidine +/- Placebo Sedation
Eligible subjects will be given 9 mg/ml saline placebo) \~ 15 min after terminating Dex's infusion.
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov