Back to resultsDexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Propofol sedation
Dexmedetomidine sedation
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Drug-Induced Sleep Endoscopy, Propofol, Dexmedetomidine
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Propofol sedation
Dexmedetomidine sedation
Arm Description
2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute.
1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05303987
First Posted
March 22, 2022
Last Updated
October 17, 2022
Sponsor
Erin Kirkham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT05303987
Brief Title
Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
Official Title
Trial of Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
August 31, 2026 (Anticipated)
Study Completion Date
August 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erin Kirkham
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Drug-Induced Sleep Endoscopy, Propofol, Dexmedetomidine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
A coordinator and anesthesiologist will be unblinded.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Propofol sedation
Arm Type
Experimental
Arm Description
2.5 mg/kg loading dose, then continue at an infusion of 250 mcg/kg/minute.
Arm Title
Dexmedetomidine sedation
Arm Type
Experimental
Arm Description
1 mcg/kg loading dose, then continue at an infusion of 1 mcg/kg/hour
Intervention Type
Drug
Intervention Name(s)
Propofol sedation
Intervention Description
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
Intervention Name(s)
Dexmedetomidine sedation
Intervention Description
After induction with sevoflurane then Dexmedetomidine will be given.
If adequate sedation cannot be attained then a ketamine rescue can be given.
Primary Outcome Measure Information:
Title
Mean obstruction score at the tongue base
Description
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.
Time Frame
During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roselyn Nsenga
Phone
734-615-4052
Email
ronsenga@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Kirkham
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roselyn Nsenga
Phone
734-615-4052
Email
ronsenga@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Erin Kirkham
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32876805
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.
Results Reference
background
PubMed Identifier
24096043
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.
Results Reference
background
PubMed Identifier
27212000
Citation
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.
Results Reference
background
Learn more about this trial
Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
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