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Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT01344759
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
29
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
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
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • Precedex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Cross Sectional Area of the Pharyngeal Airway [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

    1. Obstructive Index Until Recovery Room Discharge [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 [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 [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 [During MRI and until recovery room discharge - approximately 30-250 minutes]

      The patient's oxygen saturation on room air.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Months to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01344759
    Other Study ID Numbers:
    • CCHMC 2009-0514
    First Posted:
    Apr 29, 2011
    Last Update Posted:
    Aug 8, 2018
    Last Verified:
    Aug 1, 2018
    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
    Dexmedetomidine
    Propofol

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Propofol Dexmedetomidine
    Arm/Group Description 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. 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.
    Period Title: Overall Study
    STARTED 30 30
    COMPLETED 30 28
    NOT COMPLETED 0 2

    Baseline Characteristics

    Arm/Group Title Propofol Dexmedetomidine Total
    Arm/Group Description 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. 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. Total of all reporting groups
    Overall Participants 30 30 60
    Age (Count of Participants)
    <=18 years
    30
    100%
    30
    100%
    60
    100%
    Between 18 and 65 years
    0
    0%
    0
    0%
    0
    0%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Inter-Quartile Range) ]
    Mean (Inter-Quartile Range) [years]
    8.8
    8.3
    8.6
    Sex: Female, Male (Count of Participants)
    Female
    8
    26.7%
    8
    26.7%
    16
    26.7%
    Male
    22
    73.3%
    22
    73.3%
    44
    73.3%
    Region of Enrollment (participants) [Number]
    United States
    30
    100%
    30
    100%
    60
    100%

    Outcome Measures

    1. Primary Outcome
    Title Cross Sectional Area of the Pharyngeal Airway
    Description 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.
    Time Frame during MRI within first 10 minutes of scanning

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Propofol Dexmedetomidine
    Arm/Group Description 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 (Low dose). Baseline airway images are obtained during this time. If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team. After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose). 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 (low dose). Baseline airway images are obtained during this time. If a subject moves during baseline images a bolus of DEX 0.5 mcg/kg will be given over 3 minutes and infusion rate will be increased to 1.5 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team. After the initial set of airway images are obtained, a 2 mcg/kg bolus of DEX will be given over 10 minutes followed by an increase in the infusion rate to 3 mcg/kg/hr (high dose).
    Measure Participants 30 28
    Low Dose Sedative, Nasopharyngeal measurement
    239.9
    178.5
    High Dose Sedative, Nasopharyngeal measurement
    201.6
    235.4
    Low Dose Sedative, Retroglossal measurement
    115.1
    120.9
    High dose sedative, Retroglossal measurement
    108.1
    120.5
    2. Secondary Outcome
    Title Obstructive Index Until Recovery Room Discharge
    Description The Obstructive Index is a count of the obstructive apnea events per hour of sleep
    Time Frame During MRI and until recovery room discharge - approximately 30-250 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mild OSA and Dexmedetomidine Mild OSA and Propofol Moderate OSA and Dexmedetomidine Moderate OSA and Propofol Severe OSA and Dexmedetomidine Severe OSA and Propofol
    Arm/Group Description Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
    Measure Participants 2 7 13 10 11 13
    Mean (Inter-Quartile Range) [Apnea events/hour of sleep]
    4.2
    3.0
    8.0
    8.0
    16.7
    17.1
    3. Secondary Outcome
    Title Respiratory Disturbance Index
    Description The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.
    Time Frame During MRI and until recovery room discharge - approximately 30-250 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mild OSA and Dexmedetomidine Mild OSA and Propofol Moderate OSA and Dexmedetomidine Moderate OSA and Propofol Severe OSA and Dexmedetomidine Severe OSA and Propofol
    Arm/Group Description Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
    Measure Participants 2 7 13 10 11 13
    Mean (Inter-Quartile Range) [respir.disturbance events/hr of sleep]
    5.1
    3.2
    8.8
    7.1
    16.6
    25.2
    4. Secondary Outcome
    Title Needed Artificial Airway
    Description This is the count of the number of patients who needed an artificial airway.
    Time Frame During MRI and until recovery room discharge - approximately 30-250 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mild OSA and Dexmedetomidine Mild OSA and Propofol Moderate OSA and Dexmedetomidine Moderate OSA and Propofol Severe OSA and Dexmedetomidine Severe OSA and Propofol
    Arm/Group Description Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
    Measure Participants 2 7 13 10 11 13
    Number [Number of artifical airway events]
    0
    1
    1
    1
    2
    5
    5. Secondary Outcome
    Title Room Air SpO2
    Description The patient's oxygen saturation on room air.
    Time Frame During MRI and until recovery room discharge - approximately 30-250 minutes

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Mild OSA and Dexmedetomidine Mild OSA and Propofol Moderate OSA and Dexmedetomidine Moderate OSA and Propofol Severe OSA and Dexmedetomidine Severe OSA and Propofol
    Arm/Group Description Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX. Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
    Measure Participants 2 7 13 10 11 13
    Mean (Inter-Quartile Range) [percentage of SpO2]
    87.2
    88.0
    86.3
    89.0
    84.0
    88.0

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Propofol Dexmedetomidine
    Arm/Group Description 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. 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.
    All Cause Mortality
    Propofol Dexmedetomidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Propofol Dexmedetomidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%)
    Other (Not Including Serious) Adverse Events
    Propofol Dexmedetomidine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/30 (0%) 0/30 (0%)

    Limitations/Caveats

    Failure to standardize mouth opening, due to stimulation of the subject during manipulation of the mouth No baseline measurements were obtained while awake Many patients had Downs syndrome so the results may not apply across all patients with OSA

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Mohamed Mahmoud
    Organization Cincinnati Children's Hosptial Medical Center
    Phone 513-636-4408
    Email Mohamed.Mahmoud@cchmc.org
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT01344759
    Other Study ID Numbers:
    • CCHMC 2009-0514
    First Posted:
    Apr 29, 2011
    Last Update Posted:
    Aug 8, 2018
    Last Verified:
    Aug 1, 2018