DISE in Pediatric Sleep Disordered Breathing

January 2, 2025 updated by: University of Iowa

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: 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
Other Names:
  • Diprivan
  • Propofol-Lipuro
  • Fresenius Propoven
  • Propofol-II [DSC]
  • TEVA-Propofol
Active Comparator: 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
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
Other Names:
  • Precedex

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Principal Investigator: Sohit Kanotra, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2022

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

May 21, 2022

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202011387

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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