Airway Remodeling
Conditions
Keywords
upper, airway, dimensions, propofol, dexmedetomidine
Brief summary
Sedation is required in infants and children to successfully complete MRI while maintaining respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk during MRI examination. Therefore, appropriate drugs need to be selected, administered, and titrated to achieve these objectives. Propofol is commonly used for sedation in children in the MRI setting because of its predictability, rapid onset, and offset of action. Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and respiratory stability. The rationale of this research is to assess the effect of these drugs on the upper airway and validate their use in children with upper airway disorders.
Detailed description
Objectives The objective of this study is to compare the changes in upper airway configuration at the level of soft palate, base of tongue and tip of the epiglottis in children sedated with dexmedetomidine and propofol in children undergoing MRI. We hypothesize that the upper airway caliber will be smaller in children receiving propofol than with dexmedetomidine. Primary Outcome To measure the cross-sectional area (CSA) of the upper airway at the level of soft palate, base of the tongue and epiglottis in both groups of children at high doses of propofol and dexmedetomidine and thus compare the decrease in CSA with increasing doses of both drugs. Secondary Outcomes To measure the * anteroposterior (AP) diameter * transverse (Tr) diameter of the upper airway at the three levels in both groups of children at both low and high doses of propofol and dexmedetomidine and compare the decrease in AP and Tr diameter at increasing doses of dexmedetomidine.
Interventions
DRUGDexmedetomidine
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.
DRUGpropofol
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.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* Children undergoing MRI brain * Age 2 - 5 yrs * ASA I - II
Exclusion criteria
* OSA * Pathology of upper airway * Craniofacial anomalies * Gastroesophageal reflux * Increased intracranial pressure * Body weight of 20% more than ideal * Contraindication to the use of either drug * Failure to maintain a patent airway during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis | When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtained | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged |
| Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtained | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged |
Countries
United States
Participant flow
Pre-assignment details
1 participant was excluded prior to assignment group
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 14 |
| Total | 24 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Total | Propofol |
|---|---|---|---|
| Age, Continuous | 4 years | 3.75 years | 3.5 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 24 Participants | 14 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 participants | 24 participants | 14 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 14 |
| other Total, other adverse events | 0 / 10 | 0 / 14 |
| serious Total, serious adverse events | 0 / 10 | 0 / 14 |
Outcome results
Primary
Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis
At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.
Time frame: When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | 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 |
| Dexmedetomidine | 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 |
| Dexmedetomidine | 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 |
| Propofol | 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 | 103.9 mm2 | Standard Deviation 50.8 |
| Propofol | 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 | 68.9 mm2 | Standard Deviation 38.3 |
| Propofol | 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 | 81.6 mm2 | Standard Deviation 69.7 |
Secondary
Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged
Time frame: When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtained
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | 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 |
| Dexmedetomidine | 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 |
| Dexmedetomidine | 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 |
| Propofol | Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | AP of the Soft Palate | 9.2 mm | Standard Deviation 3.8 |
| Propofol | 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 | 8.6 mm | Standard Deviation 3.6 |
| Propofol | 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 | 7.1 mm | Standard Deviation 3.1 |
Secondary
Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged
Time frame: When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtained
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexmedetomidine | 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 |
| Dexmedetomidine | 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 |
| Dexmedetomidine | 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 |
| Propofol | 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 | 11.2 mm | Standard Deviation 6.3 |
| Propofol | Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | Tr of the Soft Palate | 13.5 mm | Standard Deviation 4.5 |
| Propofol | 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 | 9.3 mm | Standard Deviation 5.2 |