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

Primary Purpose

Airway Remodeling

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexmedetomidine
propofol
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Airway Remodeling focused on measuring upper, airway, dimensions, propofol, dexmedetomidine

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

dexmedetomidine

propofol

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
July 7, 2011
Last Updated
July 10, 2019
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01505933
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
finding it difficult to recruit.
Study Start Date
February 2012 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Remodeling
Keywords
upper, airway, dimensions, propofol, dexmedetomidine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Title
propofol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
alpha 2 agaonist
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
induction agent
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis
Description
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
Secondary Outcome Measure Information:
Title
Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
Description
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
Title
Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma R Parekh, MBBS, FRCA
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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