Trial Outcomes & Findings for Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea (NCT NCT01344759)
NCT ID: NCT01344759
Last Updated: 2018-08-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
during MRI within first 10 minutes of scanning
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Patients failed to reach sedation level
|
0
|
2
|
Baseline Characteristics
Dexmedetomidine and Propofol in Children With History of Obstructive Sleep Apnea
Baseline characteristics by cohort
| Measure |
Propofol
n=30 Participants
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
n=30 Participants
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
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
8.8 years
n=5 Participants
|
8.3 years
n=7 Participants
|
8.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during MRI within first 10 minutes of scanningThe 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.
Outcome measures
| Measure |
Propofol
n=30 Participants
* 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).
|
Dexmedetomidine
n=28 Participants
* 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).
|
Moderate OSA and Dexmedetomidine
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.
|
Moderate OSA and 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 Propofol.
|
Severe OSA and Dexmedetomidine
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.
|
Severe OSA and 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 Propofol.
|
|---|---|---|---|---|---|---|
|
Cross Sectional Area of the Pharyngeal Airway
Low Dose Sedative, Nasopharyngeal measurement
|
239.9 mm^2
Interval 185.4 to 267.2
|
178.5 mm^2
Interval 148.5 to 222.4
|
—
|
—
|
—
|
—
|
|
Cross Sectional Area of the Pharyngeal Airway
High Dose Sedative, Nasopharyngeal measurement
|
201.6 mm^2
Interval 148.9 to 291.7
|
235.4 mm^2
Interval 145.0 to 258.8
|
—
|
—
|
—
|
—
|
|
Cross Sectional Area of the Pharyngeal Airway
Low Dose Sedative, Retroglossal measurement
|
115.1 mm^2
Interval 67.8 to 167.0
|
120.9 mm^2
Interval 63.6 to 179.5
|
—
|
—
|
—
|
—
|
|
Cross Sectional Area of the Pharyngeal Airway
High dose sedative, Retroglossal measurement
|
108.1 mm^2
Interval 53.6 to 134.4
|
120.5 mm^2
Interval 50.1 to 178.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During MRI and until recovery room discharge - approximately 30-250 minutesThe Obstructive Index is a count of the obstructive apnea events per hour of sleep
Outcome measures
| Measure |
Propofol
n=2 Participants
* 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).
|
Dexmedetomidine
n=7 Participants
* 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).
|
Moderate OSA and Dexmedetomidine
n=13 Participants
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.
|
Moderate OSA and Propofol
n=10 Participants
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.
|
Severe OSA and Dexmedetomidine
n=11 Participants
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.
|
Severe OSA and Propofol
n=13 Participants
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.
|
|---|---|---|---|---|---|---|
|
Obstructive Index Until Recovery Room Discharge
|
4.2 Apnea events/hour of sleep
Interval 3.4 to 4.9
|
3.0 Apnea events/hour of sleep
Interval 2.3 to 3.5
|
8.0 Apnea events/hour of sleep
Interval 7.4 to 8.6
|
8.0 Apnea events/hour of sleep
Interval 5.9 to 8.9
|
16.7 Apnea events/hour of sleep
Interval 14.1 to 23.3
|
17.1 Apnea events/hour of sleep
Interval 14.6 to 37.0
|
SECONDARY outcome
Timeframe: During MRI and until recovery room discharge - approximately 30-250 minutesThe respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.
Outcome measures
| Measure |
Propofol
n=2 Participants
* 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).
|
Dexmedetomidine
n=7 Participants
* 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).
|
Moderate OSA and Dexmedetomidine
n=13 Participants
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.
|
Moderate OSA and Propofol
n=10 Participants
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.
|
Severe OSA and Dexmedetomidine
n=11 Participants
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.
|
Severe OSA and Propofol
n=13 Participants
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.
|
|---|---|---|---|---|---|---|
|
Respiratory Disturbance Index
|
5.1 respir.disturbance events/hr of sleep
Interval 4.8 to 5.4
|
3.2 respir.disturbance events/hr of sleep
Interval 2.4 to 4.1
|
8.8 respir.disturbance events/hr of sleep
Interval 7.7 to 9.8
|
7.1 respir.disturbance events/hr of sleep
Interval 5.9 to 9.1
|
16.6 respir.disturbance events/hr of sleep
Interval 14.3 to 19.6
|
25.2 respir.disturbance events/hr of sleep
Interval 14.7 to 41.9
|
SECONDARY outcome
Timeframe: During MRI and until recovery room discharge - approximately 30-250 minutesThis is the count of the number of patients who needed an artificial airway.
Outcome measures
| Measure |
Propofol
n=2 Participants
* 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).
|
Dexmedetomidine
n=7 Participants
* 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).
|
Moderate OSA and Dexmedetomidine
n=13 Participants
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.
|
Moderate OSA and Propofol
n=10 Participants
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.
|
Severe OSA and Dexmedetomidine
n=11 Participants
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.
|
Severe OSA and Propofol
n=13 Participants
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.
|
|---|---|---|---|---|---|---|
|
Needed Artificial Airway
|
0 Number of artifical airway events
|
1 Number of artifical airway events
|
1 Number of artifical airway events
|
1 Number of artifical airway events
|
2 Number of artifical airway events
|
5 Number of artifical airway events
|
SECONDARY outcome
Timeframe: During MRI and until recovery room discharge - approximately 30-250 minutesThe patient's oxygen saturation on room air.
Outcome measures
| Measure |
Propofol
n=2 Participants
* 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).
|
Dexmedetomidine
n=7 Participants
* 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).
|
Moderate OSA and Dexmedetomidine
n=13 Participants
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.
|
Moderate OSA and Propofol
n=10 Participants
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.
|
Severe OSA and Dexmedetomidine
n=11 Participants
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.
|
Severe OSA and Propofol
n=13 Participants
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.
|
|---|---|---|---|---|---|---|
|
Room Air SpO2
|
87.2 percentage of SpO2
Interval 86.7 to 87.7
|
88.0 percentage of SpO2
Interval 83.0 to 91.0
|
86.3 percentage of SpO2
Interval 84.8 to 87.5
|
89.0 percentage of SpO2
Interval 87.0 to 93.0
|
84.0 percentage of SpO2
Interval 77.0 to 88.8
|
88.0 percentage of SpO2
Interval 80.4 to 88.2
|
Adverse Events
Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mohamed Mahmoud
Cincinnati Children's Hosptial Medical Center
Phone: 513-636-4408
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place