Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01344759
First received: April 21, 2011
Last updated: January 26, 2016
Last verified: January 2016

April 21, 2011
January 26, 2016
June 2009
November 2011   (final data collection date for primary outcome measure)
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 (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.
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).
Complete list of historical versions of study NCT01344759 on ClinicalTrials.gov Archive Site
  • Obstructive Index Until Recovery Room Discharge [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The patient's oxygen saturation on room air.
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.
Not Provided
Not Provided
 
Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Effect of Increasing Depth of Dexmedetomidine and Propofol Anesthesia on Upper Airway Morphology 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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sleep Apnea, Obstructive
  • 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
  • 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: Propofol
    Intervention: Drug: Propofol
  • Active Comparator: Dexmedetomidine
    Intervention: Drug: Dexmedetomidine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
12 Months to 25 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01344759
CCHMC 2009-0514
Yes
Not Provided
Not Provided
Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
Not Provided
Principal Investigator: Mohamed Mahmoud, MD Children's Hospital Medical Center, Cincinnati
Children's Hospital Medical Center, Cincinnati
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP