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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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14 March 2022 |
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Main ID: |
NCT01880541 |
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Date of registration:
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06/11/2012 |
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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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Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer
HYPNOSEIN |
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Scientific title:
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Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01880541 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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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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COLOMBANI Sylvie, 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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Institut Bergonié |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female, over 18 and under 80 years
- Diagnosis of breast cancer established (Pathology)
- Life expectancy greater than 6 months
- Surgery of breast lumpectomy with or without lymph node dissection, mastectomy with or
without lymph node dissection, dissection isolated
- ASA 1 (healthy patient) or 2 (patient with moderate to high function) according to the
classification of the American Society of Anesthesiologist,
- Affiliation to a social security scheme,
- Information on the study, signed informed consent
Exclusion Criteria:
- Presence of major psychiatric disorders or psychotic behavior addiction, evaluated by
neuropsychologist at the first preoperative consultation, through the test MINI (MINI>
4 positive responses for each module)
- Presence of neurological disorders known untreated or evaluated by neuropsychologist
at the first preoperative consultation, with the MMSE test (MMSE <24)
- Patient treated morphine orally for 3 months or more
- Patient is pregnant or nursing, or of childbearing potential and not using adequate
contraception,
- Patient included in another clinical study
- Inability to undergo medical monitoring study for geographical, social or
psychological
- Patient deprived of liberty and most subject to a measure of legal protection or
unable to consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Patients With Breast Cancer and Breast Surgery Requiring
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Intervention(s)
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Other: hypnosedation
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Other: general anesthésia
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Primary Outcome(s)
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Presence of Cognitive Impairment
[Time Frame: on the 7th day following surgery]
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Secondary Outcome(s)
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Presence of Cognitive Impairment
[Time Frame: 1 month after surgery]
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Secondary ID(s)
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IB2009-71
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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