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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05303987
• Other study ID #: HUM00207865
• Secondary ID: K23HL153897
• Status: Recruiting
• Phase: Phase 2
• Start date: October 5, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Asana Williams
• Phone: 734-998-6140
• Email: asanawi[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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 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.

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Erin Kirkham	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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