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Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea

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ClinicalTrials.gov Identifier: NCT01344759
Recruitment Status : Completed
First Posted : April 29, 2011
Results First Posted : February 23, 2016
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Sleep Apnea, Obstructive
Interventions: Drug: Dexmedetomidine
Drug: Propofol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Propofol 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 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.

Participant Flow:   Overall Study
    Propofol   Dexmedetomidine
STARTED   30   30 
COMPLETED   30   28 [1] 
NOT COMPLETED   0   2 
Patients failed to reach sedation level                0                2 
[1] Two of the original DEX group subjects were removed, due to receiving dexmedetomidine and propofol.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Propofol 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 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 Total of all reporting groups

Baseline Measures
   Propofol   Dexmedetomidine   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      30 100.0%      30 100.0%      60 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Inter-Quartile Range)
 8.8 
 (5.8 to 14.3) 
 8.3 
 (4.7 to 16.1) 
 8.6 
 (5.3 to 15.2) 
Sex: Female, Male 
[Units: Participants]
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 
[Units: Participants]
     
United States   30   30   60 


  Outcome Measures

1.  Primary:   Cross Sectional Area of the Pharyngeal Airway   [ Time Frame: during MRI within first 10 minutes of scanning ]

2.  Secondary:   Obstructive Index Until Recovery Room Discharge   [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]

3.  Secondary:   Respiratory Disturbance Index   [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]

4.  Secondary:   Needed Artificial Airway   [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]

5.  Secondary:   Room Air SpO2   [ Time Frame: During MRI and until recovery room discharge - approximately 30-250 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


Results Point of Contact:  
Name/Title: Dr. Mohamed Mahmoud
Organization: Cincinnati Children's Hosptial Medical Center
phone: 513-636-4408
e-mail: Mohamed.Mahmoud@cchmc.org


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: March 12, 2018