Trial Outcomes & Findings for Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine (NCT NCT01505933)
NCT ID: NCT01505933
Last Updated: 2019-07-11
Results Overview
At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done
Results posted on
2019-07-11
Participant Flow
1 participant was excluded prior to assignment group
Participant milestones
| Measure |
Dexmedetomidine
Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.
|
Propofol
propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.
Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
14
|
|
Overall Study
COMPLETED
|
10
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=10 Participants
Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.
|
Propofol
n=14 Participants
propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.
After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.
Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4 years
n=5 Participants
|
3.5 years
n=7 Participants
|
3.75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
14 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be doneAt each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.
Outcome measures
| Measure |
Dexmedetomidine
n=10 Participants
Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0
|
Propofol
n=14 Participants
Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0
|
|---|---|---|
|
Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis
CSA of the Soft Palate
|
132.1 mm2
Standard Deviation 75.9
|
103.9 mm2
Standard Deviation 50.8
|
|
Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis
CSA of the Base of Tongue
|
122.0 mm2
Standard Deviation 82.1
|
68.9 mm2
Standard Deviation 38.3
|
|
Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis
CSA of the Tip of the Epiglottis
|
47.6 mm2
Standard Deviation 41.5
|
81.6 mm2
Standard Deviation 69.7
|
SECONDARY outcome
Timeframe: When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtainedAt each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged
Outcome measures
| Measure |
Dexmedetomidine
n=10 Participants
Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0
|
Propofol
n=14 Participants
Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0
|
|---|---|---|
|
Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
AP of the Soft Palate
|
10.2 mm
Standard Deviation 2.5
|
9.2 mm
Standard Deviation 3.8
|
|
Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
AP of the Base of the Tongue
|
11.0 mm
Standard Deviation 4.7
|
8.6 mm
Standard Deviation 3.6
|
|
Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
AP of the Tip of the Epiglottis
|
11.0 mm
Standard Deviation 7.0
|
7.1 mm
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtainedAt each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged
Outcome measures
| Measure |
Dexmedetomidine
n=10 Participants
Dexmedetomidine: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0
|
Propofol
n=14 Participants
Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0
|
|---|---|---|
|
Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
Tr of the Soft Palate
|
14.6 mm
Standard Deviation 3.1
|
13.5 mm
Standard Deviation 4.5
|
|
Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
Tr of the Base of the Tongue
|
12.4 mm
Standard Deviation 3.2
|
9.3 mm
Standard Deviation 5.2
|
|
Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
Tr of the Tip of the Epiglottis
|
12.6 mm
Standard Deviation 7.9
|
11.2 mm
Standard Deviation 6.3
|
Adverse Events
Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Propofol
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. Uma R Parekh, MBBS, DNB, FRCA, FFARCSI
Penn State Health Milton S. Hershey Medical Center
Phone: 717531-4264
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place