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

NCT01505933 | Terminated Phase 2 Results DMC

• 1 other identifier: 35165
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Remodeling

Keywords

upper; airway; dimensions; propofol; dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis

  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

• Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis

  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

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

Drug: Dexmedetomidine

propofol

ACTIVE COMPARATOR

Drug: propofol

Interventions

Dexmedetomidine 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.

Also known as: alpha 2 agaonist

dexmedetomidine

propofol 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.

Also known as: induction agent

propofol

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children undergoing MRI brain
• Age 2 - 5 yrs
• ASA I - II

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Airway Remodeling

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Early termination leading to small numbers of subjects recruited.

Results Point of Contact

• Title: Dr. Uma R Parekh, MBBS, DNB, FRCA, FFARCSI
• Organization: Penn State Health Milton S. Hershey Medical Center

uparekh@pennstatehealth.psu.edu

717531-4264

Study Officials

• Uma R Parekh, MBBS, FRCA

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professsor in Anesthesiology

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: January 9, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: April 30, 2019
• Last Updated: July 11, 2019
• Results First Posted: July 11, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)