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

NCT ID: NCT01505933

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2019-04-30

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.

Conditions

Airway Remodeling

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

alpha 2 agaonist; induction agent

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Uma R Parekh

Assistant Professsor in Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uma R Parekh, MBBS, FRCA

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

35165

Identifier Type: -

Identifier Source: org_study_id