RECRUITING

Dex +/- Caffeine Sedation in a Post-MRI Recovery in a Pediatric Population

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-09-09
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06538584

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Undergo Magnetic Resonance Imaging (MRI) scan
  2. * Age ≥3 and ≤ 12 yr old
  3. * Both Male and Female
  4. * Weight ≤33.3 kg
  5. * American Society of Anesthesiologists ASA) physical status 1-3
  6. * No History of Arrhythmia (3-leads Electrocardiogram \[EKG\] applied before and after the sedation) or congenital heart disease
  7. * Capable of obtaining consent from at least one parent
  8. * No history of liver and kidney impairment
  9. * No history of head trauma
  10. * No prior history of difficulty with anesthesia
  11. * No personal or family history of malignant hyperthermia
  1. * Age \<3 or \>12
  2. * Weight \>33.3 kg
  3. * ASA physical status \> 3
  4. * History Arrhythmia, congenital heart disease, liver, and kidney diseases
  5. * Prior difficulty with anesthesia
  6. * Personal or family history of malignant hyperthermia
  7. * Unable to obtain consent
  8. * History of head trauma
  9. * Female subjects who are pregnant

Contacts and Locations

Study Contact

Zheng Xie, MD, PhD
CONTACT
773-702-2667
jxie@bsd.uchicago.edu
Al McAuley
CONTACT
773-834-3274
amcauley1@bsd.uchicago.edu

Principal Investigator

Zheng Xie, MD,PhD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of Chicago Medical Center
Chicago, Illinois, 60637
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Zheng Xie, MD,PhD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Dexmedetomidine sedation
  • Caffeine citrate stimulant
  • Pediatric surgical population

Additional Relevant MeSH Terms

  • Enhanced Recovery After Surgery in a Pediatric Population