Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)

NCT00894751 | Terminated Phase 1 DMC

• 1 other identifier: 2008-0281
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine if there is a significant difference in the quality of care between the investigators' two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI. Quality of care will be measured by time spent in the MRI room as well as parental satisfaction, frequency of interruptions of the MRI scan, incidence-severity of respiratory complications, post anesthesia agitation, and time spent in the induction room, MRI room, and Post-Anesthesia Care Unit (PACU).

Conditions

Magnetic Resonance Imaging; Anesthesia

Keywords

dexmedetomidine and propofol for MRI; quality of care between two anesthetic agents for MRI

Outcome Measures

Primary Outcomes (1)

• The primary outcome variable will be the time spent in the MRI room

  2 years

Secondary Outcomes (1)

• Secondary outcome variables include incidence-severity of respiratory complications

  2 years

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI.

Drug: dexmedetomidine

propofol

ACTIVE COMPARATOR

Determine if there is a significant difference in the quality of care between our two standard anesthesia techniques for children undergoing a MRI of the body and/or extremity MRI.

Drug: propofol

Interventions

dexmedetomidine DRUG

dexmedetomidine general anesthesia for MRI

dexmedetomidine

propofol DRUG

propofol general anesthesia for MRI

propofol

Eligibility Criteria

• Age: 12 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects presenting as out-patients, scheduled to receive an anesthetic for MRI of body (spine, chest, abdomen, and/or pelvis) and/or extremity (arm and/or leg).
• The subject must be a candidate for both anesthetic techniques. This decision will be made by a staff member of the Department of Anesthesiology. This staff member will not be a member of the study team and will obtain the consent for Anesthesia.
• The subjects must be 12 months to 7 years (inclusive of the seventh year).
• The subject's legally authorized representative has given written informed consent to participate in the study.

You may not qualify if:

• The subject is residing in the Pediatric Intensive Care Unit, the Cardiac Intensive Care Unit, or Neonatal Intensive Care Unit.
• Anxiolytic medication is ordered before the MRI (e.g., midazolam or ketamine).
• The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
• The subject has life-threatening, medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6).
• The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is.
• For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III).
• The subject is allergic to or has a contraindication to any of the drugs used in the study.
• The subject has previously been treated under this protocol.
• The subject has a tracheostomy or other mechanical airway device.
• The subject has received within the past 12 hours an oral or intravenous alpha-adrenergic, beta-adrenergic agonist, or antagonist drugs (e.g., clonidine, propranolol, albuterol).
• The subject is not scheduled to receive anesthesia-sedation care for the MRI.
• The subject received one of the anesthetic regimens for the same MRI during the past six months.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Propofol

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 21, 2020

Record last verified: 2020-08

Locations

US (1)