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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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3 August 2015 |
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Main ID: |
NCT02510586 |
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Date of registration:
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24/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Sevoflurane and Hyperperfusion Syndrome
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Scientific title:
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Effect of Sevoflurane-induced Postconditioning on the Incidence of Postoperative Cerebral Hyperperfusion Syndrome After Revascularization Surgery in Adult Patients With Moyamoya Disease |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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152 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02510586 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
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Phase:
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N/A
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Contacts
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Name:
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Hee Pyung Park, MD, PhD |
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Address:
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Telephone:
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82-2-2072-2466 |
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Email:
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hppark@snu.ac.kr |
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Affiliation:
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Name:
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Hee Pyung Park, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients receiving cerebral revascularization surgery due to moyamoya disease
Exclusion Criteria:
- Patients who do not agree to the study
- Patients with uncontrolled diabetes or hypertension
- Patients using cyclooxygenase2 inhibitor or with previously using cyclooxygenase2
inhibitor
- Patients with acute renal failure
- Patients with previous intervention related with moyamoya disease
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperperfusion Syndrome
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Moyamoya Disease
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Intervention(s)
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Drug: Sevoflurane
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Primary Outcome(s)
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The incidence of postoperative cerebral hyperperfusion syndrome
[Time Frame: postoperative day 15]
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Secondary Outcome(s)
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The incidence of a new onset postoperative brain hematoma
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.]
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The incidence of unrecovered neurological deficit
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.]
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The incidence of a new onset postoperative cerebral ischemia
[Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks.]
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Secondary ID(s)
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Sevo_postconditioning
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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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