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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Iowa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sohit Kanotra, MD, University of Iowa

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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