Two Anesthetic Techniques in Magnetic Resonance Imaging (MRI)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Children's Hospital Medical Center, Cincinnati.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Hospital Medical Center, Cincinnati
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00894751
First received: May 6, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Magnetic Resonance Imaging Anesthesia |
Drug: dexmedetomidine Drug: propofol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | A Qualitative Comparison of Two Anesthetic Techniques in Children Undergoing Magnetic Resonance Imaging |
Resource links provided by NLM:
Further study details as provided by Children's Hospital Medical Center, Cincinnati:
Primary Outcome Measures:
- The primary outcome variable will be the time spent in the MRI room [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Secondary outcome variables include incidence-severity of respiratory complications [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 160 |
| Study Start Date: | January 2009 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: dexmedetomidine
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
dexmedetomidine general anesthesia for MRI
|
|
Active Comparator: propofol
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
propofol general anesthesia for MRI
|
Eligibility| Ages Eligible for Study: | 12 Months to 7 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00894751
Contacts
| Contact: JUNZHENG WU, MD | 5132523489 | junzheng.wu@cchmc.org |
Locations
| United States, Ohio | |
| Cincinnati Children's Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: junzheng wu, MD 513-636-4408 junzheng.wu@cchmc.org | |
| Principal Investigator: Junzheng wu, MD | |
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
More Information
No publications provided
| Responsible Party: | Mohamed Mahmoud, Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00894751 History of Changes |
| Other Study ID Numbers: | 2008-0281 |
| Study First Received: | May 6, 2009 |
| Last Updated: | May 6, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
dexmedetomidine and propofol for MRI quality of care between two anesthetic agents for MRI |
Additional relevant MeSH terms:
|
Anesthetics Propofol Dexmedetomidine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anesthetics, Intravenous Anesthetics, General 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 May 16, 2013