Recruiting
Phase 1
Phase 2

Dex with Caffeine

Sponsor:

University of Chicago

Code:

NCT06538584

Conditions

Enhanced Recovery After Surgery in a Pediatric Population

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Accepted

Interventions

Caffeine citrate 15mg/kg

0.9% Sodium Citrate

Study Details

Brief 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.

Conditions

Enhanced Recovery After Surgery in a Pediatric Population

Study ID

NCT06538584

Start date

Sep 9, 2024

Status verified date

Sep, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 12

Healthy Volunteers: Accepted

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 >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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Caffeine 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.

0.9% 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.

Primary outcome measure

  • Improve rate of wakefulness post surgery [ Time Frame: Up to 2 hours ]

Central Contacts and Locations

Central contacts

Locations

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

More Information

Sponsor

University of Chicago

Last update posted

Sep 12, 2025

Last verified

Sep, 2025

Keywords

  • Dexmedetomidine sedation
  • Caffeine citrate stimulant
  • Pediatric surgical population

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2025-09-12.