NCT06756971

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

Withdrawn Phase 2/Phase 3 Last updated 2 January 2025

What this trial tests

Phase 2/Phase 3 trial testing Propofol in Sleep Disordered Breathing. Withdrawn.

Timeline

1 June 2022

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	University of Iowa
Phase	Phase 2/Phase 3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	diagnostic
Start date	1 June 2022
Primary completion	1 November 2023
Estimated completion	1 November 2023

Drugs / interventions tested

• Propofol (Propofol) — full drug profile →
• Dexmedetomidine (dexmedetomidine) — full drug profile →

Conditions studied

• Sleep Disordered Breathing — all drugs for Sleep Disordered Breathing →
• Drug Induced Sleep Disorder — all drugs for Drug Induced Sleep Disorder →

Sponsor

University of Iowa

Who can join

Adults 1 Month to 18, any sex, with Sleep Disordered Breathing or Drug Induced Sleep Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.