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

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ClinicalTrials.gov Identifier: NCT01505933
Recruitment Status : Terminated (finding it difficult to recruit.)
First Posted : January 9, 2012
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Uma R Parekh, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Airway Remodeling Drug: Dexmedetomidine Drug: propofol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Changes in Upper Airway Dimensions With Dexmedetomidine and Propofol in Children Undergoing MRI
Actual Study Start Date : February 2012
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dexmedetomidine 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.

Other Name: alpha 2 agaonist

Active Comparator: propofol Drug: 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.

Other Name: induction agent




Primary Outcome Measures :
  1. Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis [ 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 ]
    At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.


Secondary Outcome Measures :
  1. Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis [ 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 ]
    At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged

  2. Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis [ 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 ]
    At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged



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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505933


Locations
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United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Uma R Parekh, MBBS, FRCA Milton S. Hershey Medical Center
  Study Documents (Full-Text)

Documents provided by Uma R Parekh, Milton S. Hershey Medical Center:
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Responsible Party: Uma R Parekh, Assistant Professsor in Anesthesiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01505933    
Other Study ID Numbers: 35165
First Posted: January 9, 2012    Key Record Dates
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Uma R Parekh, Milton S. Hershey Medical Center:
upper
airway
dimensions
propofol
dexmedetomidine
Additional relevant MeSH terms:
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Airway Remodeling
Pathological Conditions, Anatomical
Dexmedetomidine
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action