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NCT Number: NCT01344759

Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.

The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

12 month–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
  • Subjects must be 12 months to 25 years of age (inclusive)
  • Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study

Exclusion criteria

  • The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
  • The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
  • The subject has a tracheostomy or other mechanical airway device
  • The subject is not scheduled to receive anesthesia-sedation care for the MRI
  • The subject has a history or a family (parent or sibling) history of malignant hyperthermia.

Treatment and study plan

Dexmedetomidine

Drug

Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.

Other names: Precedex

Propofol

Drug

Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.

Other names: Diprivan

Primary outcomes

  1. Cross Sectional Area of the Pharyngeal Airway

    Time frame: during MRI within first 10 minutes of scanning

    The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.

Secondary outcomes

  1. Obstructive Index Until Recovery Room Discharge

    Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes

    The Obstructive Index is a count of the obstructive apnea events per hour of sleep

  2. Respiratory Disturbance Index

    Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes

    The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.

  3. Needed Artificial Airway

    Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes

    This is the count of the number of patients who needed an artificial airway.

  4. Room Air SpO2

    Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes

    The patient's oxygen saturation on room air.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 29, 2011
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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