Clinical trial NCT01505933: Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine
Official title: Comparison of Changes in Upper Airway Dimensions With Dexmedetomidine and Propofol in Children Undergoing MRI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Airway Remodeling
Keywords: upper
airway
dimensions
propofol
dexmedetomidine
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2012-01-09
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis
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
Secondary outcomes:
measure: Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
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 obtained
measure: Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
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 obtained
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Uma R Parekh, MBBS, FRCA
role: PRINCIPAL_INVESTIGATOR
References: