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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Milton S. Hershey Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Uma R Parekh, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01505933
First received: July 7, 2011
Last updated: January 4, 2012
Last verified: January 2012
  Purpose

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 Intervention
Airway Remodeling
Drug: Dexmedetomidine
Drug: propofol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of Changes in Upper Airway Dimensions With Dexmedetomidine and Propofol in Children Undergoing MRI

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • cross-sectional area (CSA) of the upper airway at the level of soft palate, base of the tongue and epiglottis [ Time Frame: When immobile for 5 min, after stabilisation on low dose infusion of the drug, the first set of airway images will be obtained. Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.. ] [ Designated as safety issue: No ]
    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 [ Time Frame: When immobile for 5 min, after stabilisation on low dose infusion of the drug, the first set of airway images will be obtained. Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.. ] [ Designated as safety issue: No ]
    At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged

  • transverse diameter at the level of soft palate, base of tongue and tip of the epiglottis [ Time Frame: When immobile for 5 min, after stabilisation on low dose infusion of the drug, the first set of airway images will be obtained. Image acquisitions will be repeated approximately 5 min after the increase in infusion rate.. ] [ Designated as safety issue: No ]
    At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged.


Estimated Enrollment: 40
Study Start Date: February 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505933

Contacts
Contact: Uma R Parekh, MBBS, FRCA 717 531- 4264 uparekh@hmc.psu.edu
Contact: Arabinda Choudhary, MD 717 531- 5306 achoudhary@hmc.psu.edu

Locations
United States, Pennsylvania
Penn State Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Uma R Parekh, MBBS, FRCA         
Sub-Investigator: Arabinda Choudhary, MD         
Sub-Investigator: Priti Dalal, MD         
Sub-Investigator: Patrick McQuillan, MD         
Sub-Investigator: Timothy Mosher, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Uma R Parekh, MBBS, FRCA Milton S. Hershey Medical Center
  More Information

No publications provided

Responsible Party: Uma R Parekh, Assistant Professsor in Anesthesiology, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01505933     History of Changes
Other Study ID Numbers: 35165
Study First Received: July 7, 2011
Last Updated: January 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
upper
airway
dimensions
propofol
dexmedetomidine

Additional relevant MeSH terms:
Airway Remodeling
Pathological Conditions, Anatomical
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
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

ClinicalTrials.gov processed this record on July 29, 2014