DISE in Pediatric Sleep Disordered Breathing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Contribution of Drug Induced Sleep Endoscopy of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome

NCT03845062

Obstructive Sleep Apnea Hypopnea Syndrome

COMPLETED

Dexamethasone Treatment for OSA in Children

NCT05638087

Obstructive Sleep Apnea

ACTIVE_NOT_RECRUITING PHASE3

Sedation With Dexmedetomidine During Cardiac Catheterization

NCT01072643

Pulmonary Hypertension

TERMINATED PHASE2/PHASE3

Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children

NCT02056379

Stridor

UNKNOWN NA

The Bronchiolitis in Hospitalized Infants Study

NCT05994183

Bronchiolitis

WITHDRAWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Disordered Breathing Drug Induced Sleep Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Propofol

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

Intervention Type DRUG

Dexmedetomidine

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Diprivan Fresenius Propoven Propofol-Lipuro Propofol-II [DSC] TEVA-Propofol Precedex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No