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Randomization of Propofol or Dexmedetomidine
This is a clinical trial comparing two sedative agents: propofol (a GABA-A receptor agonist) and dexmedetomidine (an alpha-2 adrenergic agonist) for sedation in pediatric patients.
This is a clinical trial comparing two sedative agents: propofol (a GABA-A receptor agonist) and dexmedetomidine (an alpha-2 adrenergic agonist) for sedation in pediatric patients. Used for Sedation in pediatric patients (comparative trial).
At a glance
| Generic name | Randomization of Propofol or Dexmedetomidine |
|---|---|
| Sponsor | Children's Hospital Los Angeles |
| Drug class | Sedative/Hypnotic agents |
| Target | GABA-A receptor (propofol); Alpha-2 adrenergic receptor (dexmedetomidine) |
| Modality | Small molecule |
| Therapeutic area | Anesthesia/Sedation |
| Phase | FDA-approved |
Mechanism of action
Propofol enhances inhibitory GABAergic neurotransmission in the central nervous system to produce rapid sedation and anesthesia. Dexmedetomidine selectively activates alpha-2 adrenergic receptors in the brain and spinal cord to produce sedation and analgesia with preserved airway reflexes. This trial randomizes patients to receive one agent or the other to compare efficacy and safety profiles in children.
Approved indications
- Sedation in pediatric patients (comparative trial)
Common side effects
- Hypotension
- Respiratory depression
- Bradycardia
- Injection site pain (propofol)
- Dry mouth (dexmedetomidine)
Key clinical trials
- Awareness Neuraxial Versus General Anesthesia in Frail Patients Undergoing Laparoscopic or Robotic Abdominopelvic Surgery. (NA)
- Comparison of Anesthetic Techniques for Early Recovery After Ankle Arthroscopy (NA)
- Opioid-Free vs Opioid-Based Anesthesia in Bariatric Surgery (NA)
- Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS) (NA)
- Dexmedetomidine and Myocardial Protection (NA)
- Propofol-Only Versus Dexmedetomidine-Propofol in Children Undergoing Magnetic Resonance Imaging (PHASE4)
- Sedation Efficacy and Safety of Remazolam Besylate in Ventilated Surgical Critically Ill Patients (PHASE4)
- Night-time Dexmedetomidine-esketamine Infusion and Sleep Quality in ICU Patients (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
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