Airway Dimension Study in Children Undergoing MRI Sedated With Propofol and Dexmedetomidine

Airway Remodeling Clinical Trial

Official title:

Comparison of Changes in Upper Airway Dimensions With Dexmedetomidine and Propofol in Children Undergoing MRI

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01505933
• Other study ID #: 35165
• Status: Terminated
• Phase: Phase 2
• Start date: February 2012
• Est. completion date: April 30, 2019

Study information

• Verified date: July 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 30, 2019
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Remodeling

Intervention

Drug:
• 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
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.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	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	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
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	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