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.
Dexmedetomidine Versus Propofol Sedation for Drug-Induced Sleep Endoscopy in Pediatric Obstructive Sleep Apnea
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.
Intervention / Treatment
-
Propofol Sedation (DRUG)After induction with sevoflurane then Propofol will be initiated. If adequate sedation cannot be attained then a ketamine rescue can be given.
-
Dexmedetomidine sedation (DRUG)After induction with sevoflurane then Dexmedetomidine will be given. If adequate sedation cannot be attained then a ketamine rescue can be given.
Condition or Disease
- Obstructive Sleep Apnea
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 3 Years to 11 Years |
| Enrollment: | 90 (ESTIMATED) |
| Allocation: | Randomized |
| Primary Purpose: | Diagnostic |
MaskingA coordinator and anesthesiologist will be unblinded. QUADRUPLE:
|
|
Clinical Trial Dates
| Start date: | Oct 05, 2022 | ACTUAL |
|---|---|---|
| Primary Completion: | Aug 31, 2026 | ESTIMATED |
| Completion Date: | Aug 31, 2026 | ESTIMATED |
| Study First Posted: | Mar 31, 2022 | ACTUAL |
| Last Updated: | Oct 17, 2022 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Participant Groups
-
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
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 3 |
| Maximum Age: | 11 |
| Age Groups: | Child |
| Healthy Volunteers: | Yes |
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
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
This clinical trial is recruiting
Are you interested in participating in this trial or others? We'd love to help.
Primary Outcomes
More Details
| NCT Number: | NCT05303987 |
|---|---|
| Other IDs: | HUM00207865 |
| Study URL: | https://clinicaltrials.gov/study/NCT05303987 |
Last updated: Sep 29, 2023