Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

Trial of Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea

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

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 11
Healthy Volunteers: f
View:

• Diagnosed with Obstructive sleep apnea (OSA) by the following criteria: Obstructive Apnea Index (OAI) ≥ 1 or Apnea Hypopnea Index (AHI) ≥ 1.5, confirmed on nocturnal, laboratory-based polysomnography within the previous 12 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab.

• Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.

• Clinical determination by the child's otolaryngologist surgeon that the child would benefit from sleep endoscopy prior to adenotonsillectomy due to one or more reported risk factors for residual sleep apnea after surgery, which may include:

‣ Obese (\>95th percentile of body mass index for age)

⁃ Severe preoperative OSA (AHI ≥10 events/hour)

⁃ Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity;

⁃ African American race

⁃ Age ≥7 years old

• Male or Female ages 3.00 - 11.99 years of age at the time of consent

• Parent/guardian ability to understand and willingness to sign a written informed consent..

• Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Brittany Nordhaus
nbrittan@med.umich.edu
734-232-1740
Time Frame
Start Date: 2022-10-05
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 90
Treatments
Experimental: Propofol sedation
2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute.
Experimental: Dexmedetomidine sedation
1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour
Related Therapeutic Areas
Sponsors
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Leads: Erin Kirkham

This content was sourced from clinicaltrials.gov