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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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19 February 2015 |
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Main ID: |
NCT00389883 |
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Date of registration:
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18/10/2006 |
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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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Anaesthesia for Supratentorial Tumor Resection
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Scientific title:
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Anaesthesia for Supratentorial Tumor Resection : a Double-blind Comparison of Target Plasma Concentration of Propofol-remifentanil and Sevoflurane-sufentanil |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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69 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00389883 |
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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/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Souhayl DAHMANI, 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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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient scheduled for supratentorial brain tumors remove.
- Age : 18 to 75.
- ASA 1 or 2.
Exclusion Criteria:
- Disagree of patient to participate
- Intubation required in the postoperative care unit
- Contraindication of one of the anesthetics used in the study
- Pregnancy
- Craniotomy in the frontal area (no depth of anesthesia monitoring)
- Patient's inability to quantified its pain.
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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Supratentorial Neoplasms
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Intervention(s)
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Drug: Comparison of two anesthetics protocol
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Primary Outcome(s)
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Time from discontinuing anesthesia and extubation.
[Time Frame: during 24 hours]
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Secondary Outcome(s)
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Quality of emergence from anesthesia : agitation, postoperative pain, nausea and vomiting, cognitive functions.
[Time Frame: during 24 hours]
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Speed of emergence from anesthesia : time from discontinuing anesthesia to spontaneous breathing, opening the eyes, response to simple order and discharge from postoperative care unit.
[Time Frame: during 24 hours]
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Quality of surgical procedure : Coma glasgow scale, surgical procedure difficulties.
[Time Frame: during 24 hours]
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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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