Back to resultsDexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea, Obstructive
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea, MRI, Pediatrics, Dexmedetomidine, Propofol, Anesthesia
Eligibility Criteria
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.
Sites / Locations
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Propofol
Dexmedetomidine
Arm Description
Outcomes
Primary Outcome Measures
Cross Sectional Area of the Pharyngeal Airway
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
The Obstructive Index is a count of the obstructive apnea events per hour of sleep
Respiratory Disturbance Index
The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.
Needed Artificial Airway
This is the count of the number of patients who needed an artificial airway.
Room Air SpO2
The patient's oxygen saturation on room air.
Full Information
NCT ID
NCT01344759
First Posted
April 21, 2011
Last Updated
August 6, 2018
Sponsor
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT01344759
Brief Title
Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Official Title
Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology in Children With History of Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
Obstructive Sleep Apnea, MRI, Pediatrics, Dexmedetomidine, Propofol, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propofol
Arm Type
Active Comparator
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Precedex
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention 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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Mahmoud, MD
Organizational Affiliation
Children's Hospital Medical Center, Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
12. IPD Sharing Statement
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Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
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