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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 : August 8, 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
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Propofol Dexmedetomidine
Hide 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 [1]
Not Completed 0 2
Reason Not Completed
Patients failed to reach sedation level             0             2
[1]
Two of the original DEX group subjects were removed, due to receiving dexmedetomidine and propofol.
Arm/Group Title Propofol Dexmedetomidine Total
Hide 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 Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 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, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
8.8
(5.8 to 14.3)
8.3
(4.7 to 16.1)
8.6
(5.3 to 15.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
8
  26.7%
8
  26.7%
16
  26.7%
Male
22
  73.3%
22
  73.3%
44
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Cross Sectional Area of the Pharyngeal Airway
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Propofol Dexmedetomidine
Hide 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).
Overall Number of Participants Analyzed 30 28
Median (95% Confidence Interval)
Unit of Measure: mm^2
Low Dose Sedative, Nasopharyngeal measurement
239.9
(185.4 to 267.2)
178.5
(148.5 to 222.4)
High Dose Sedative, Nasopharyngeal measurement
201.6
(148.9 to 291.7)
235.4
(145.0 to 258.8)
Low Dose Sedative, Retroglossal measurement
115.1
(67.8 to 167.0)
120.9
(63.6 to 179.5)
High dose sedative, Retroglossal measurement
108.1
(53.6 to 134.4)
120.5
(50.1 to 178.4)
2.Secondary Outcome
Title Obstructive Index Until Recovery Room Discharge
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 2 7 13 10 11 13
Mean (Inter-Quartile Range)
Unit of Measure: Apnea events/hour of sleep
4.2
(3.4 to 4.9)
3.0
(2.3 to 3.5)
8.0
(7.4 to 8.6)
8.0
(5.9 to 8.9)
16.7
(14.1 to 23.3)
17.1
(14.6 to 37.0)
3.Secondary Outcome
Title Respiratory Disturbance Index
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 2 7 13 10 11 13
Mean (Inter-Quartile Range)
Unit of Measure: respir.disturbance events/hr of sleep
5.1
(4.8 to 5.4)
3.2
(2.4 to 4.1)
8.8
(7.7 to 9.8)
7.1
(5.9 to 9.1)
16.6
(14.3 to 19.6)
25.2
(14.7 to 41.9)
4.Secondary Outcome
Title Needed Artificial Airway
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 2 7 13 10 11 13
Measure Type: Number
Unit of Measure: Number of artifical airway events
0 1 1 1 2 5
5.Secondary Outcome
Title Room Air SpO2
Hide Description The patient's oxygen saturation on room air.
Time Frame During MRI and until recovery room discharge - approximately 30-250 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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.

Overall Number of Participants Analyzed 2 7 13 10 11 13
Mean (Inter-Quartile Range)
Unit of Measure: percentage of SpO2
87.2
(86.7 to 87.7)
88.0
(83.0 to 91.0)
86.3
(84.8 to 87.5)
89.0
(87.0 to 93.0)
84.0
(77.0 to 88.8)
88.0
(80.4 to 88.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Propofol Dexmedetomidine
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Propofol Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Propofol Dexmedetomidine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
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
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
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: August 8, 2018