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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 March 2015 |
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Main ID: |
NCT01001585 |
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Date of registration:
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21/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Anesthetic Effects in Mitochondrial Disease
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Scientific title:
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Anesthetic Effects in Mitochondrial Disease |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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55 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01001585 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Supportive Care
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Danield I Sessler, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients presenting to the operating room for muscle biopsy as part of their
diagnostic workup for possible mitochondrial disease.
Exclusion Criteria:
- Patients more than 16 years of age.
- Patients with concurrent acute infectious disease.
- Patients not tolerating a slow induction for emotional reasons.
- Initial BIS measurement of less than 95.
- Documented pulmonary disease.
Age minimum:
12 Months
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mitochondrial Disease
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Intervention(s)
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Drug: sevoflurane
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Primary Outcome(s)
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Measure cardiovascular stability and electrical brain activity during slow induction with sevoflurane.
[Time Frame: during induction]
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Secondary Outcome(s)
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Use cardiovascular and electrical brain measurements to limit amount of sevoflurane and predict individual sensitivity.
[Time Frame: during induction]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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