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

NCT ID: NCT05303987

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-05
• Study Completion Date: 2026-08-31

Brief 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Propofol sedation

2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute.

Group Type: EXPERIMENTAL

Propofol sedation

Intervention Type: DRUG

After induction with sevoflurane then Propofol will be initiated.

If adequate sedation cannot be attained then a ketamine rescue can be given.

Dexmedetomidine sedation

1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour

Group Type: EXPERIMENTAL

Dexmedetomidine sedation

Intervention Type: DRUG

After induction with sevoflurane then Dexmedetomidine will be given.

If adequate sedation cannot be attained then a ketamine rescue can be given.

Interventions

Propofol sedation

After induction with sevoflurane then Propofol will be initiated.

If adequate sedation cannot be attained then a ketamine rescue can be given.

Intervention Type: DRUG

Dexmedetomidine sedation

After induction with sevoflurane then Dexmedetomidine will be given.

If adequate sedation cannot be attained then a ketamine rescue can be given.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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 12 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 of age at the time of consent

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.

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erin Kirkham

OTHER

Sponsor Role: lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Responsible Party

Erin Kirkham

Assistant Professor of Otolaryngology-Head and Neck Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Erin Kirkham, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brittany Nordhaus

Role: CONTACT

nbrittan@med.umich.edu

734-232-1740

Facility Contacts

Brittany Nordhaus

Role: primary

nbrittan@med.umich.edu

734-232-1740

References

Kirkham EM, Hoi K, Melendez JB, Henderson LM, Leis AM, Puglia MP 2nd, Chervin RD. Propofol versus dexmedetomidine during drug-induced sleep endoscopy (DISE) for pediatric obstructive sleep apnea. Sleep Breath. 2021 Jun;25(2):757-765. doi: 10.1007/s11325-020-02179-x. Epub 2020 Sep 2.

Reference Type: BACKGROUND

PMID: 32876805 (View on PubMed)

Mahmoud M, Jung D, Salisbury S, McAuliffe J, Gunter J, Patio M, Donnelly LF, Fleck R. Effect of increasing depth of dexmedetomidine and propofol anesthesia on upper airway morphology in children and adolescents with obstructive sleep apnea. J Clin Anesth. 2013 Nov;25(7):529-41. doi: 10.1016/j.jclinane.2013.04.011. Epub 2013 Oct 2.

Reference Type: BACKGROUND

PMID: 24096043 (View on PubMed)

Kandil A, Subramanyam R, Hossain MM, Ishman S, Shott S, Tewari A, Mahmoud M. Comparison of the combination of dexmedetomidine and ketamine to propofol or propofol/sevoflurane for drug-induced sleep endoscopy in children. Paediatr Anaesth. 2016 Jul;26(7):742-51. doi: 10.1111/pan.12931. Epub 2016 May 23.

Reference Type: BACKGROUND

PMID: 27212000 (View on PubMed)

Other Identifiers

K23HL153897

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00207865

Identifier Type: -

Identifier Source: org_study_id