← Back to Search

Dexmedetomidine vs Propofol Sedation for Pediatric Obstructive Sleep Apnea

Phase 2

Recruiting

Led By Erin Kirkham, MD MPH

Research Sponsored by Erin Kirkham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Considered to be a surgical candidate for adenotonsillectomy to treat OSA by a 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters

Awards & highlights

Study Summary

This trial will compare the effects of two anesthetics on upper airway collapse during sleep endoscopy in children with sleep apnea.

Who is the study for?

This trial is for children aged 3 to under 12 with obstructive sleep apnea confirmed by a sleep study. They should benefit from a sleep endoscopy before tonsil and adenoid removal surgery, especially if they are obese, have severe OSA, small tonsils but severe symptoms, are African American or over 7 years old. Kids who've had previous upper airway surgeries or have certain medical risks or allergies can't participate.Check my eligibility

What is being tested?

The study compares the effects of two sedatives—Dexmedetomidine and Propofol—during drug-induced sleep endoscopy in kids with obstructive sleep apnea. It aims to see how each drug affects airway collapse during the procedure and if this relates to persistent OSA after surgery.See study design

What are the potential side effects?

Possible side effects include reactions specific to Dexmedetomidine such as low blood pressure, slow heart rate, dry mouth; and for Propofol: pain at injection site, low blood pressure, fast or slow heart rate.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for surgery to treat sleep apnea, as confirmed by an ear, nose, and throat doctor.

Select...

My child is recommended for sleep endoscopy before adenotonsillectomy due to high risk of remaining sleep apnea.

Select...

I have been diagnosed with sleep apnea based on a sleep study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters

This trial's timeline: 3 weeks for screening, Varies for treatment, and during drug induced sleep endoscopy (dise) procedure, as judged subsequently by video review by the three raters for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean obstruction score at the tongue base

Trial Design

2Treatment groups

Experimental Treatment

Group I: Propofol sedationExperimental Treatment1 Intervention

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

Group II: Dexmedetomidine sedationExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexmedetomidine sedation

2015

Completed Phase 3

~110

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,835 Previous Clinical Trials

47,310,580 Total Patients Enrolled

Erin KirkhamLead Sponsor

Erin Kirkham, MD MPHPrincipal InvestigatorUniversity of Michigan

Media Library

Propofol sedation Clinical Trial Eligibility Overview. Trial Name: NCT05303987 — Phase 2

Obstructive Sleep Apnea Research Study Groups: Dexmedetomidine sedation, Propofol sedation

Obstructive Sleep Apnea Clinical Trial 2023: Propofol sedation Highlights & Side Effects. Trial Name: NCT05303987 — Phase 2

Propofol sedation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05303987 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you give some insight into the risks of Propofol sedation?

"Although there is some evidence that propofol sedation is safe, it only received a score of 2 because this is classified as a Phase 2 trial. This means that while there are no data supporting efficacy, there are data suggesting the safety of propofol sedation."

Answered by AI

Are we still able to sign people up for this experiment?

"Yes, this trial is looking for participants. The listing on clinicaltrials.gov suggests that the study was posted on October 5th and updated on the 17th of the same month."

Answered by AI

Could you explain the age requirements for this clinical trial?

"According to the study's inclusion criteria, only children aged 3 to 11 can participate. Out of the 403 clinical trials that exist, this one is unique in its age range as 51 are for patients under 18 and 252 trials are geared towards adults over 65."

Answered by AI

Who would be an ideal candidate for this test group?

"This study is enrolling 90 participants with sleep apnea syndromes aged 3 and 11. Most importantly, candidates are required to meet the following 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 ad"

Answered by AI

How many people are choosing to participate in this clinical trial?

"The answer is affirmative, according to clinicaltrials.gov this experiment requires more participants and is currently looking for volunteers. This study was first brought to light on October 5th, 2020 with the most recent update taking place on October 17th of the same year. Only one location is enrolling patients but they are seeking a total of ninety individuals."

Answered by AI

Recent research and studies

Sleep and BreathingJournal

Propofol Versus Dexmedetomidine During Drug-induced Sleep Endoscopy (DISE) for Pediatric Obstructive Sleep Apnea

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.

Pediatric AnesthesiaJournal

Comparison of the Combination of Dexmedetomidine and Ketamine to Propofol or Propofol/sevoflurane for Drug-induced Sleep Endoscopy in Children

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.

Journal of Clinical AnesthesiaJournal

Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children and Adolescents with Obstructive Sleep Apnea

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.

clinicaltrials.govStudy