Study Summary
This trial will compare the effects of two anesthetics on upper airway collapse during sleep endoscopy in children with sleep apnea.
Eligible Conditions
- Obstructive Sleep Apnea
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters
During Drug Induced Sleep Endoscopy (DISE) procedure, as judged subsequently by video review by the three raters
Mean obstruction score at the tongue base
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
Dexmedetomidine sedation
1 of 2
Propofol sedation
1 of 2
Experimental Treatment
90 Total Participants · 2 Treatment Groups
Primary Treatment: Propofol sedation · No Placebo Group · Phase 2
Dexmedetomidine sedation
Drug
Experimental Group · 1 Intervention: Dexmedetomidine sedation · Intervention Types: DrugPropofol sedation
Drug
Experimental Group · 1 Intervention: Propofol sedation · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine sedation
2015
Completed Phase 3
~110
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,588 Previous Clinical Trials
46,945,909 Total Patients Enrolled
Erin KirkhamLead Sponsor
Eligibility Criteria
Age 3 - 11 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have severe preoperative OSA.
Parent/guardian ability to understand and willingness to sign a written informed consent..
You have symptoms of sleep apnea, but you have small tonsils.
Parent/guardian must understand/read/speak English or Spanish and be able and willing to complete questionnaires.
References
- Kirkham, Erin M., Karen Hoi, Jonathan B. Melendez, Lauren M. Henderson, Aleda M. Leis, Michael P. Puglia II, and Ronald D. Chervin. 2020. “Propofol Versus Dexmedetomidine During Drug-induced Sleep Endoscopy (DISE) for Pediatric Obstructive Sleep Apnea”. Sleep and Breathing. Springer Science and Business Media LLC. doi:10.1007/s11325-020-02179-x.
- Kandil, Ali, Rajeev Subramanyam, Mohamed Monir Hossain, Stacey Ishman, Sally Shott, Anurag Tewari, and Mohamed Mahmoud. 2016. “Comparison of the Combination of Dexmedetomidine and Ketamine to Propofol or Propofol/sevoflurane for Drug-induced Sleep Endoscopy in Children”. Edited by Jerrold Lerman. Pediatric Anesthesia. Wiley. doi:10.1111/pan.12931.
- Mahmoud, Mohamed, Dorothy Jung, Shelia Salisbury, John McAuliffe, Joel Gunter, Mario Patio, Lane F. Donnelly, and Robert Fleck. 2013. “Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children and Adolescents with Obstructive Sleep Apnea”. Journal of Clinical Anesthesia. Elsevier BV. doi:10.1016/j.jclinane.2013.04.011.
- Erin Kirkham 2022. "Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05303987.
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Conditions
Cancer Related
Treatments