DISE in Pediatric Sleep Disordered Breathing

Phase 2

Withdrawn

• Conditions: Sleep Disordered Breathing; Drug Induced Sleep Disorder
• Interventions: Drug: Propofol; Drug: Dexmedetomidine

• Registration Number: NCT06756971
• Lead Sponsor: University of Iowa

Brief Summary

Adenotonsillar hypertrophy is the most common reason for children to have sleep disordered breathing (SDB). Even though adenotonsillectomy improves sleep apnea in children, 20-40% of children will still have persistent SDB. Drug Induced Sleep Endoscopy (DISE) is a tool that dynamically evaluates the upper airway during simulated sleep. It identifies sites of upper airway obstruction and/or collapse. It is used to predict which children will get better if their tonsils and adenoids are removed, and which children have other reasons for SDB. DISE is done during a state of simulated sleep. Different anesthetic medications are currently being used. However, there is no identified ideal anesthetic medication to simulate natural sleep. Propofol and Dexmedetomidine are the most frequently used, either alone or in combination with other medications. The aim is to perform a head-to-head study comparing those 2 commonly used regimens. The investigator would like to learn how the anesthetic medication affects performing the procedure and how well our patients tolerate it. This helps us identify an ideal regimen that can be a standardized DISE protocol in the pediatric population in the future. Our objective is to determine which anesthetic regimen, Dexmedetomidine or Propofol, is safer and more efficacious. This will be a randomized controlled trial at the University of Iowa Stead Family Children's Hospital. Children with sleep disordered breathing will undergo DISE and subsequent surgical procedure based on the level of obstruction found during DISE. Via randomization the child will be preselected to have a specific anesthetic for the procedure, either Dexmedetomidine or Propofol. The investigator will record information related to the medications used, the vital signs, the ability to perform DISE fully, the findings seen on DISE and the surgery performed. Consent will be obtained from the legal guardian or parent with legal authority to consent.

Detailed Description

Drug-induced sleep endoscopy (DISE) in children has gained popularity in the past 10 years. Its most valuable use is in patients with sleep disordered breathing (SDB). DISE is capable of identifying dynamic sites of upper airway obstruction and or collapse during sleep, beyond the tonsils and adenoids. It is also capable of identifying the degree of dynamic obstruction caused by different anatomical structures. Currently, pediatric patients with SDB diagnosed either clinically with the help of a validated sleep questionnaire or on the basis of sleep study and undergo surgery depending on the level of the obstruction. The surgery most commonly performed is adenotonsillectomy. In order to diagnose the level of obstruction DISE is performed. Currently, there is a lack in consensus regarding the ideal anesthetic regimen to simulate natural sleep and poor agreement regarding DISE anesthetic protocols among experts. An ideal agent would provide sufficient analgesia under near-physiologic settings and prevent substantial airway collapse, respiratory depression, and cardiovascular effects. It should have a predictable period of action and a smooth emergence. Multiple anesthetic regimens have been used for DISE. This includes inhalation anesthesia such as Sevoflurane, total intravenous anesthesia (TIVA) such as Propofol alone or with Remifentanil, and Dexmedetomidine alone or with Ketamine. Propofol and Dexmedetomidine are the most frequently used regimens, either alone or in combination with another medication. Most studies in this regard are retrospective in nature, with only a handful of prospective studies. To date, no randomized controlled trials have been performed to address anesthetic regimens to perform DISE in children. One randomized controlled trial in adults compared Propofol and Dexmedetomidine as anesthetic regimens for DISE and concluded that Dexmedetomidine could satisfy the DISE requirement and had no significant side effects on cardiovascular changes and less interference of breathing. Given the difference between children and adults in pathophysiology, risk factors for the diseases and tolerance of medication, the findings cannot be claimed to be similar in children unless proven. The aim is to perform a head-to-head study comparing the 2 commonly used regimens Propofol and Dexmedetomidine in children with SDB. This helps us identify a safer and more efficacious regimen that can be a standardized DISE protocol in the pediatric population in the future.

Study Timeline

• Study First Submitted: 2022-05-21
• Study Start: 2022-06-01
• Primary Completion: 2023-11
• Study Completion: 2023-11
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-02
• Last Update Submitted: 2025-01-02
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Children 1 month-18 years of age
• Clinical diagnosis of sleep disordered breathing (SDB) either based on a Pediatric sleep questionnaire (>33% on modified Pediatric Sleep Questionnaire (PSQ)) or Sleep study
• Subject is deemed a surgical candidate for undergoing DISE, adenotonsillectomy or DISE directed surgery

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Exclusion Criteria

• Adult patients
• Hypersensitivity to propofol or dexmedetomidine or any of their components,
• Allergies to eggs, egg products, soybeans, or soy products,
• Congenital cardiac disease, cardiac conduction system pathology, and increased pulmonary artery pressure or decreased cardiac output (e.g., right-sided heart failure, septic shock).
• Children who are receiving medicines with rate-slowing action on the atrioventricular node (eg, digoxin, nifedipine)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	Arm 1: Propofol 1. PO Versed (Benzodiazepine) preoperatively 2. Obtain baseline bispectral index (BIS) monitor 3. Mask induction with Sevoflurane 4. Intravenous access 5. Propofol bolus 0.5-2 mg/kg to start followed by infusion 200-350 mcg/kg/min 6. Wait around 2 minutes 7. BIS monitor with Propofol on board
Dexmedetomidine	Dexmedetomidine	Arm 2: Dexmedetomidine 1. PO Versed (Benzodiazepine) preoperatively 2. Obtain baseline BIS monitor 3. Mask induction with Sevoflurane 4. Intravenous access 5. Dexmedetomidine bolus 0.5-3 mcg/kg to start followed by infusion 0.5-2mcg/kg/hr 6. Wait around 10 mins 7. BIS monitor with Dexmedetomidine on board

Primary Outcome Measures

Name	Time	Method
Comparing Dexmedetomidine and Propofol for successful DISE (Drug Induced Sleep Endoscopy) procedure in-terms regarding which drug works better without causing side effects	5-20 minutes