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Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344759
First Posted: April 29, 2011
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
  Purpose

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.


Condition Intervention Phase
Sleep Apnea, Obstructive Drug: Dexmedetomidine Drug: Propofol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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.

  • 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.

  • Room Air SpO2 [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]
    The patient's oxygen saturation on room air.


Enrollment: 60
Study Start Date: June 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propofol Drug: Propofol
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 Name: Diprivan
Active Comparator: Dexmedetomidine Drug: Dexmedetomidine
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 Name: Precedex

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study.
  2. Subjects must be 12 months to 25 years of age (inclusive)
  3. 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:

  1. 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).
  2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine.
  3. The subject has a tracheostomy or other mechanical airway device
  4. The subject is not scheduled to receive anesthesia-sedation care for the MRI
  5. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344759


Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Mohamed Mahmoud, MD Children's Hospital Medical Center, Cincinnati
  More Information

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01344759     History of Changes
Other Study ID Numbers: CCHMC 2009-0514
First Submitted: April 21, 2011
First Posted: April 29, 2011
Results First Submitted: August 20, 2015
Results First Posted: February 23, 2016
Last Update Posted: August 28, 2017
Last Verified: July 2017

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Obstructive Sleep Apnea
MRI
Pediatrics
Dexmedetomidine
Propofol
Anesthesia

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Propofol
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action