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Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01344759
First received: April 21, 2011
Last updated: April 28, 2011
Last verified: April 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels (soft palate and base of the tongue).


Secondary Outcome Measures:
  • Patient obstructive index and airway maintenance until Recovery Room discharge [ Time Frame: during MRI and until Recovery Room discharge - approximately 30 - 250 minutes ] [ Designated as safety issue: No ]
    (a) anteroposterior dimension and transverse dimension of the pharyngeal airway of the patients measured at two levels: soft palate and base of the tongue, (b) patient movement during scan,(c) episodes of low oxygen saturation(d) placement of adjunct airway such as oral/nasal airway, laryngeal mask airway or endotracheal tube, (e) examine the relationship between OSA severity and episodes of desaturation and artificial airway placement, (f) PACU discharge time (g) arterial blood pressure and heart rate relative to baseline following dexmedetomidine and propofol.


Estimated Enrollment: 60
Study Start Date: June 2009
Estimated Study Completion Date: February 2012
Estimated 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

Ages Eligible for Study:   12 Months to 25 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344759

Contacts
Contact: Mohamed Mahmoud, MD 513636 4408 mohamed.mahmoud@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Mohamed Mahmoud, MD    513-636-4408    mohamed.mahmoud@cchmc.org   
Principal Investigator: Mohamed Mahmoud, MD         
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: Mohamed Mahmoud, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT01344759     History of Changes
Other Study ID Numbers: CCHMC 2009-0514
Study First Received: April 21, 2011
Last Updated: April 28, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014