Dexmedetomidine vs Propofol Sedation for Pediatric Obstructive Sleep Apnea
What You Need to Know Before You Apply
What is the purpose of this trial?
This research study is designed to learn, first, whether two anesthetics have different effects on collapse seen within the upper airway during sleep endoscopy. A second purpose is to learn whether collapse at several levels of the upper airway is associated with obstructive sleep apnea that persists after adenotonsillectomy, the surgery that removes the tonsils and adenoids.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is dexmedetomidine safe for use in children?
Dexmedetomidine, also known as Precedex, is generally well-tolerated in children for sedation, with common side effects including low blood pressure and slow heart rate, which usually resolve without treatment. It is not associated with breathing problems, making it a safe option for sedation in various pediatric procedures.12345
How does the drug dexmedetomidine differ from propofol for pediatric obstructive sleep apnea?
Dexmedetomidine is unique because it simulates natural sleep with minimal impact on breathing, making it potentially safer for children with obstructive sleep apnea who are sensitive to breathing issues caused by sedatives. In contrast, propofol may lead to more airway obstruction and lower oxygen levels, although it acts faster to induce sleep.26789
What data supports the effectiveness of the drug Dexmedetomidine for sedation in pediatric obstructive sleep apnea?
Who Is on the Research Team?
Erin Kirkham
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for children aged 3 to under 12 with obstructive sleep apnea confirmed by a sleep study. They should benefit from a sleep endoscopy before tonsil and adenoid removal surgery, especially if they are obese, have severe OSA, small tonsils but severe symptoms, are African American or over 7 years old. Kids who've had previous upper airway surgeries or have certain medical risks or allergies can't participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dexmedetomidine or Propofol sedation during the Drug Induced Sleep Endoscopy (DISE) procedure
Follow-up
Participants are monitored for safety and effectiveness after the DISE procedure
What Are the Treatments Tested in This Trial?
Interventions
- Dexmedetomidine
- Propofol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Erin Kirkham
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator