Clinical trial NCT06756971: DISE in Pediatric Sleep Disordered Breathing
Official title: Comparison Between Propofol and Dexmedetomidine as Anesthetic Protocols for Drug Induced Sleep Endoscopy (DISE) in Pediatric Patients With Sleep Disordered Breathing: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Sleep Disordered Breathing
Drug Induced Sleep Disorder
Keywords: Drug induced sleep endoscopy
sleep disordered breathing
DISE directed surgery
children
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

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)

Primary outcomes:
measure: Comparing Dexmedetomidine and Propofol for successful DISE (Drug Induced Sleep Endoscopy) procedure in-terms regarding which drug works better without causing side effects
timeFrame: 5-20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Iowa
name: Sohit Kanotra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.