Dexmedetomidine vs Propofol Sedation for Pediatric Obstructive Sleep Apnea

Overseen By Brittany Nordhaus

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Erin Kirkham

Disqualifiers: Previous adenotonsillectomy, Major medical diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two sedation drugs, dexmedetomidine (also known as Precedex) and propofol, to assess their effects on the upper airway during sleep in children with obstructive sleep apnea (OSA). Researchers aim to determine if these drugs cause different levels of airway collapse and if this collapse relates to OSA that persists after tonsil and adenoid removal surgery. Children diagnosed with OSA and considered for surgery might be suitable participants, especially if they have other factors that could lead to ongoing sleep apnea. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, providing valuable insights into potential improvements in managing OSA.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that dexmedetomidine is generally safe for children with obstructive sleep apnea (OSA). It helps keep them calm while maintaining important reflexes that clear their airways. Some studies note that children may take longer to wake up after surgery when sedated with dexmedetomidine, but it remains safe.

Propofol is also commonly used for sedation, but it has a smaller safety margin, especially for older children and girls. It can cause brief pauses in breathing when first administered. Although propofol is usually not used for deep sedation in children with OSA, it can be safe for those with central sleep apnea, where the brain doesn't send the right signals to breathe. Both treatments have been used before, but each has specific safety considerations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for pediatric obstructive sleep apnea because they offer potentially safer and more effective sedation options. Dexmedetomidine is unique because it provides sedation with less respiratory depression compared to traditional sedatives, which is crucial for children with sleep apnea who already have breathing challenges. Propofol, while commonly used, is being studied for its ability to provide quick and deep sedation, which can be beneficial during brief procedures. These treatments are being explored to see if they can better manage sedation while minimizing risks for young patients with this condition.

What evidence suggests that this trial's treatments could be effective for pediatric obstructive sleep apnea?

This trial will compare dexmedetomidine and propofol sedation for pediatric obstructive sleep apnea. Studies have shown that dexmedetomidine may be a suitable option for children with obstructive sleep apnea (OSA) during sleep endoscopy. It generally affects the main features of OSA less and doesn't significantly lower oxygen levels, potentially maintaining airway reflexes better while the child is sedated. In contrast, propofol, administered to participants in another arm of this trial, can sometimes cause more airway collapse and lower oxygen levels, despite its faster onset of sedation. These findings suggest that while both drugs are usable, dexmedetomidine might better prevent additional airway issues during these procedures. ^{1 2 3 6 7}

Who Is on the Research Team?

Erin Kirkham

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

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

Exclusion Criteria

Allergy to eggs, egg products, soybeans or soybean products.

I am allergic to or cannot take certain anesthesia drugs.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Dexmedetomidine or Propofol sedation during the Drug Induced Sleep Endoscopy (DISE) procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the DISE procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dexmedetomidine
• Propofol

Trial Overview 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.

How Is the Trial Designed?

Group I: Propofol sedation Experimental Treatment 1 Intervention

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

Group II: Dexmedetomidine sedation Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Erin Kirkham

Lead Sponsor

Trials

1

Recruited

90+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study of 117 children aged 1-18 with sleep disordered breathing, there was no significant difference in the frequency of ≥ 50% airway obstruction between those sedated with propofol and those sedated with dexmedetomidine during DISE procedures.

The results suggest that both sedatives are equally effective in assessing upper airway obstruction in children, indicating that the choice of sedative may not impact the findings of airway obstruction in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Propofol versus dexmedetomidine during drug-induced sleep endoscopy (DISE) for pediatric obstructive sleep apnea. Kirkham, EM., Hoi, K., Melendez, JB., et al.[2021]

In a study involving 91 pediatric patients, dexmedetomidine was found to be a well-tolerated alternative sedative for non-intubated moderate or deep sedation, with a low incidence of serious adverse events.

While respiratory depression and hypotension were the most common treatment-emergent adverse events, they were manageable and consistent with dexmedetomidine's known safety profile, indicating its potential for safe use in children during elective procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation. Jooste, EH., Hammer, GB., Reyes, CR., et al.[2020]

Dexmedetomidine significantly reduces the incidence of perioperative respiratory adverse events (PRAEs) such as cough, breath holding, and laryngospasm in children, based on a meta-analysis of 10 randomized controlled trials involving 1,056 patients.

In addition to lowering the risk of PRAEs, dexmedetomidine also decreases heart rate and extends post-anesthesia care unit stay by about 11 minutes, indicating its potential to improve airway function and safety during pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexmedetomidine on preventing perioperative respiratory adverse events in children: A systematic review and meta‑analysis of randomized controlled trials. Zhang, J., Yin, J., Li, Y., et al.[2023]

In a study of 82 children undergoing MRI sleep studies, dexmedetomidine was found to be effective for anesthesia, allowing for interpretable MRI results in 98% of cases, similar to propofol's 100%.

Dexmedetomidine significantly reduced the need for artificial airway support during the MRI, with only 12% of children requiring it compared to 35% in the propofol group, suggesting it may be a safer option for children with obstructive sleep apnea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of dexmedetomidine with propofol for magnetic resonance imaging sleep studies in children. Mahmoud, M., Gunter, J., Donnelly, LF., et al.[2022]

In a review of 5 randomized controlled trials involving 270 adults with obstructive sleep apnea, dexmedetomidine was found to have fewer adverse effects on respiratory function and resulted in higher satisfaction among endoscopic performers compared to propofol.

However, while dexmedetomidine showed better respiratory safety, it also had a higher risk of failed sedation, whereas propofol allowed for quicker onset of sleep but was associated with lower oxygen saturation levels and a greater risk of hypoxemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Propofol versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy: A Meta-Analysis of Randomized Controlled Trials. Chen, YT., Sun, CK., Wu, KY., et al.[2023]

In a study of 50 patients with mild obstructive sleep apnea, dexmedetomidine sedation resulted in significantly fewer cases of upper airway obstruction compared to propofol sedation (11.5% vs. 41.7%).

The need for airway intervention was lower in the dexmedetomidine group, with only 3.8% requiring an artificial airway compared to 20.8% in the propofol group, suggesting dexmedetomidine may be a safer option for sedation in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of upper airway patency in patients with mild obstructive sleep apnea during dexmedetomidine or propofol sedation: a prospective, randomized, controlled trial. Shin, HJ., Kim, EY., Hwang, JW., et al.[2019]

Dexmedetomidine was safely used to sedate a pediatric patient during 12 radiation therapy sessions, demonstrating its effectiveness as a sedative and anesthetic adjuvant.

The use of dexmedetomidine resulted in smooth induction and quick recovery while causing minimal respiratory depression, highlighting its favorable safety profile in pediatric sedation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine as the primary sedative agent for brain radiation therapy in a 21-month old child. Shukry, M., Ramadhyani, U.[2013]

In a study of 75 children aged over 5 years requiring general anesthesia, intranasal dexmedetomidine resulted in significantly better sedation during parental separation compared to oral midazolam, with 69.4% of dexmedetomidine patients achieving satisfactory sedation versus 40.5% for midazolam.

Intranasal dexmedetomidine was well-tolerated and did not cause significant changes in heart rate or blood pressure, indicating it is a safe option for pre-medication in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-medication before dental procedures: A randomized controlled study comparing intranasal dexmedetomidine with oral midazolam. Sathyamoorthy, M., Hamilton, TB., Wilson, G., et al.[2020]

In a study of 24 pediatric patients undergoing airway reconstruction, dexmedetomidine was found to be well tolerated and safe, particularly for short-term intubation, with no significant adverse effects reported.

Dexmedetomidine may serve as a beneficial alternative to propofol for sedation during the periextubation period, allowing for easily reversible sedation, although further research is needed to explore its long-term safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine use in pediatric airway reconstruction. Silver, AL., Yager, P., Purohit, P., et al.[2022]

Intravenous dexmedetomidine is effective for sedation in mechanically ventilated patients and during procedures, reducing the need for additional sedatives like propofol or midazolam.

It is generally well tolerated, does not cause respiratory depression, and while it may lead to hypotension and bradycardia, these side effects typically resolve on their own.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmedetomidine: a guide to its use for sedation in the US. Keating, GM., Hoy, SM., Lyseng-Williamson, KA.[2022]

In a study of 56 children with obstructive sleep apnea (OSA) who underwent drug-induced sleep endoscopy (DISE) using dexmedetomidine and ketamine, at least one site of obstruction was identified in all patients, regardless of whether their OSA was REM- or NREM-predominant.

Post-surgery, children with REM-predominant OSA showed significant improvements in their obstructive apnea-hypopnea index (oAHI), sleep efficiency, total sleep time, and oxygen saturation levels, indicating that DISE can effectively guide surgical interventions for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of pediatric drug-induced sleep endoscopy for REM-predominant obstructive sleep apnea. Smith, DF., He, S., Peddireddy, NS., et al.[2021]

Intranasal dexmedetomidine provided significantly better sedation compared to oral alprazolam in morbidly obese patients, with sedation scores of 3.20 in the DEX group versus 2.40 in the AZ group after 45 minutes (P = 0.034).

Despite both groups showing similar heart rates and mean arterial pressures during procedures, the DEX group had a significantly lower heart rate, indicating a potentially safer profile for sedation in this sensitive patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study to evaluate the effect of intranasal dexmedetomidine versus oral alprazolam as a premedication agent in morbidly obese patients undergoing bariatric surgery. Jayaraman, L., Sinha, A., Punhani, D.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8007082/

Effectiveness of pediatric drug-induced sleep endoscopy for ... We demonstrate that DISE using dexmedetomidine and ketamine is useful to evaluate airway obstruction in some children with REM-predominant OSA.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/pan.14290

Outcomes of dexmedetomidine sedation for drug‐induced ... Conclusions. Dexmedetomidine alone or along with ketamine provided acceptable sedation in majority of the patients with obstructive sleep apnea ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1389945725001017

Effects of dexmedetomidine and propofol on the key ... Dexmedetomidine had less impact on OSA endotypic traits compared to propofol, and had no negative effects on AHI and SpO 2.

4. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.6592

Upper Airway Reflexes are Preserved During ... This study demonstrated that dexmedetomidine is a reasonable anesthetic option to sedate children with obstructive sleep apnea, especially those presenting for ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2794983

Effect of Intranasal Dexmedetomidine or Midazolam for ... Dexmedetomidine has been proven to be effective in reducing the occurrence of PRAEs in children with congenital heart disease, but there is no ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04877639

NCT04877639 | Safety and Efficacy of Esmketamine ... Study Overview. Brief Summary. A comparative study on the safety and efficacy of esmketamine versus Dexmedetomidine during drug induced sleep endoscopy in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224003416

Dexmedetomidine in paediatric anaesthesia: a call for ... The principal message of this study is that children receiving dexmedetomidine in the operating room stay longer in the PACU before discharge to the ward.