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

NCT05303987 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HUM00207865K23HL153897
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Drug-Induced Sleep Endoscopy; Propofol; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Mean obstruction score at the tongue base

  The degree of obstruction is scored on a 4-point scale as 0% (0), \<50% (1), 50-99% (2), or 100% (3). Scores from the 3 surgeons will be averaged for use in analysis.

  During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters

Study Arms (2)

Propofol sedation

EXPERIMENTAL

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

Drug: Propofol sedation

Dexmedetomidine sedation

EXPERIMENTAL

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

Drug: Dexmedetomidine sedation

Interventions

Propofol sedation DRUG

After induction with sevoflurane then Propofol will be initiated. If adequate sedation cannot be attained then a ketamine rescue can be given.

Propofol sedation

Dexmedetomidine sedation DRUG

After induction with sevoflurane then Dexmedetomidine will be given. If adequate sedation cannot be attained then a ketamine rescue can be given.

Dexmedetomidine sedation

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Previous adenotonsillectomy or other upper airway surgery (including tracheostomy) with the exception of isolated adenoidectomy if it occurred \>18 months prior to recruitment.
• 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
• History of allergic reaction to or contraindication to receiving propofol, dexmedetomidine, ketamine or sevoflurane
• Allergy to eggs, egg products, soybeans or soybean products.
• Contraindication to receiving general anesthesia

Sponsors & Collaborators

• Erin Kirkham: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (3)

• 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.

  PMID: 32876805 BACKGROUND

• 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.

  PMID: 24096043 BACKGROUND

• 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.

  PMID: 27212000 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Erin Kirkham, MD MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brittany Nordhaus

CONTACT

734-232-1740; nbrittan@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A coordinator and anesthesiologist will be unblinded.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Otolaryngology-Head and Neck Surgery

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: October 5, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 29, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)