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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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26 September 2016 |
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Main ID: |
NCT02558569 |
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Date of registration:
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22/09/2015 |
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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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The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block
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Scientific title:
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The Use of Fentanyl in General Anesthesia for Craniotomy With or Without 0.5% Levobupivacaine Scalp Block: A Randomized Controlled Trial |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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128 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02558569 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Manee Raksakietisak, 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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Mahidol University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- supratentorial brain tumor
Exclusion Criteria:
- tumor size>4 cm
- Glasgow Coma Score (GCS) <15
- already intubated
- uncontrolled hypertension
- can not communicate
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Brain Tumor
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Intervention(s)
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Drug: Levobupivacaine
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Other: NSS
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Primary Outcome(s)
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The total dose of fentanyl being used during craniotomy
[Time Frame: One day]
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Secondary Outcome(s)
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Awakening time from general anesthesia
[Time Frame: One day]
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Secondary ID(s)
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359/2558(EC3
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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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