RECRUITING

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

Conditions

Obstructive Sleep Apnea Drug-Induced Sleep Endoscopy Propofol Dexmedetomidine

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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

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.

Official Title

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

Quick Facts

Study Start:2022-10-05

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05303987

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 11 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. 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 6 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab. 2. Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist. 3. 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: 1. Obese (\>95th percentile of body mass index for age) 2. Severe preoperative OSA (AHI ≥10 events/hour) 3. Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity; 4. African American race 5. Age ≥7 years old 4. Male or Female ages 3.00 - 11.99 years 5. Parent/guardian ability to understand and willingness to sign a written informed consent.. 6. Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.	1. Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred \>18 months prior to recruitment. 2. Major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results 3. History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane 4. Allergy to eggs, egg products, soybeans or soybean products. 5. Contraindication to receiving general anesthesia

Inclusion Criteria

Exclusion Criteria

1. 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 6 months scored using American Academy of Sleep Medicine pediatric criteria in an accredited sleep lab.
2. Considered to be a surgical candidate for adenotonsillectomy to treat OSA by an board-certified or board-eligible otolaryngologist.
3. 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:
1. Obese (\>95th percentile of body mass index for age)
2. Severe preoperative OSA (AHI ≥10 events/hour)
3. Discordance between awake physical exam (eg. small tonsils) and sleep apnea symptoms or severity;
4. African American race
5. Age ≥7 years old
4. Male or Female ages 3.00 - 11.99 years
5. Parent/guardian ability to understand and willingness to sign a written informed consent..
6. Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.

1. Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred \>18 months prior to recruitment.
2. Major medical diagnosis that may be exacerbated by the study treatment, pose undue risk to the patient, or that may impact interpretation of study results
3. History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane
4. Allergy to eggs, egg products, soybeans or soybean products.
5. Contraindication to receiving general anesthesia

Contacts and Locations

Study Contact

Asana Williams

CONTACT

734-998-6140

asanawi@med.umich.edu

Principal Investigator

Erin Kirkham, MD MPH

PRINCIPAL_INVESTIGATOR

University of Michigan

Study Locations (Sites)

University of Michigan

Ann Arbor, Michigan, 48109

United States

Collaborators and Investigators

Sponsor: Erin Kirkham

Erin Kirkham, MD MPH, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2022-10-05

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2022-10-05

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

Drug-Induced Sleep Endoscopy
Propofol
Dexmedetomidine

Additional Relevant MeSH Terms

Obstructive Sleep Apnea