DISE in Pediatric Sleep Disordered Breathing

NCT06756971 | Withdrawn Phase 2

• 1 other identifier: 202011387
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleep Disordered Breathing; Drug Induced Sleep Disorder

Keywords

Drug induced sleep endoscopy; sleep disordered breathing; DISE directed surgery; children

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Propofol

ACTIVE COMPARATOR

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

Drug: Propofol

Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Interventions

Propofol DRUG

Propofol will be administered until the patients is in an optimal plane that mimics natural sleep while spontaneously breathing to allow for a DISE evaluation

Also known as: Diprivan, Fresenius Propoven, Propofol-Lipuro, Propofol-II [DSC], TEVA-Propofol

Propofol

Dexmedetomidine DRUG

Dexmedetomidine will be administered until the patients is in an optimal plane that mimics natural sleep while spontaneously breathing to allow for a DISE evaluation

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Iowa: lead

Related Publications (6)

• Friedman NR, Parikh SR, Ishman SL, Ruiz AG, El-Hakim H, Ulualp SO, Wootten CT, Koltai PJ, Chan DK. The current state of pediatric drug-induced sleep endoscopy. Laryngoscope. 2017 Jan;127(1):266-272. doi: 10.1002/lary.26091. Epub 2016 Jun 16.

  PMID: 27311407 BACKGROUND

• Liu KA, Liu CC, Alex G, Szmuk P, Mitchell RB. Anesthetic management of children undergoing drug-induced sleep endoscopy: A retrospective review. Int J Pediatr Otorhinolaryngol. 2020 Dec;139:110440. doi: 10.1016/j.ijporl.2020.110440. Epub 2020 Oct 14.

  PMID: 33080472 BACKGROUND

• Zhao LL, Liu H, Zhang YY, Wei JQ, Han Y, Han L, Yang JP. A Comparative Study on Efficacy and Safety of Propofol versus Dexmedetomidine in Sleep Apnea Patients undergoing Drug-Induced Sleep Endoscopy: A CONSORT-Prospective, Randomized, Controlled Clinical Trial. Biomed Res Int. 2018 Nov 1;2018:8696510. doi: 10.1155/2018/8696510. eCollection 2018.

  PMID: 30515416 BACKGROUND

• Kandil A, Subramanyam R, Hossain MM, Ishman S, Shott S, Tewari A, Mahmoud M. Comparison of the combination of dexmedetomidine and ketamine to propofol or propofol/sevoflurane for drug-induced sleep endoscopy in children. Paediatr Anaesth. 2016 Jul;26(7):742-51. doi: 10.1111/pan.12931. Epub 2016 May 23.

  PMID: 27212000 BACKGROUND

• Gazzaz MJ, Isaac A, Anderson S, Alsufyani N, Alrajhi Y, El-Hakim H. Does drug-induced sleep endoscopy change the surgical decision in surgically naive non-syndromic children with snoring/sleep disordered breathing from the standard adenotonsillectomy? A retrospective cohort study. J Otolaryngol Head Neck Surg. 2017 Feb 13;46(1):12. doi: 10.1186/s40463-017-0190-6.

  PMID: 28193298 BACKGROUND

• Baldassari CM, Lam DJ, Ishman SL, Chernobilsky B, Friedman NR, Giordano T, Lawlor C, Mitchell RB, Nardone H, Ruda J, Zalzal H, Deneal A, Dhepyasuwan N, Rosenfeld RM. Expert Consensus Statement: Pediatric Drug-Induced Sleep Endoscopy. Otolaryngol Head Neck Surg. 2021 Oct;165(4):578-591. doi: 10.1177/0194599820985000. Epub 2021 Jan 5.

  PMID: 33400611 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

Propofol; Dexmedetomidine

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sohit Kanotra, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Once consent is obtained, the patient will be recruited. Name and surgical date will be provided to our statistician. Permuted block randomization will be performed. The patient will either receive Propofol or Dexmedetomidine as the anesthetic regimen intraoperatively. This will be delivered by the anesthesia team. The surgeon will be blinded, so as the patient. The anesthetist will not be blinded. DISE, adenotonsillectomy or DISE directed surgery will be performed. Data will be collected by the research team throughout the procedure and post procedure. This project does not involve the evaluation, or testing, of the safety and/or efficacy of a medical device or a new drug. This is an interventional study, in which the investigators are randomly assigning subjects to one of the two anesthetics, Propofol or Dexmedetomidine. All patients will have cardiopulmonary monitoring, and intravenous access.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study will randomize n=120 study participants undergoing DISE to one of two anesthetic agents, Propofol or Dexmedetomidine. With equal allocation to each arm (n=60 per group).

Study Record Dates

• First Submitted: May 21, 2022
• First Posted: January 3, 2025
• Study Start: June 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share