Status:
COMPLETED
Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer
Lead Sponsor:
Institut Bergonié
Conditions:
Patients With Breast Cancer and Breast Surgery Requiring
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The emergence of cognitive disorders after surgery under general anesthesia (GA) is the second leading cause of patient complaints (after dental debris caused by intubation techniques). These cognitiv...
Detailed Description
For twenty years, hypnosedation is offered to patients who underwent surgery as an alternative to other anesthetic techniques (general anesthesia and locoregional), in some European and Anglo-Saxon ho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01880541
Start Date
December 1 2010
End Date
December 1 2017
Last Update
March 4 2022
Active Locations (3)
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1
Centre Paul Strauss
Strasbourg, Alsace, France, 67000
2
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
3
Centre Oscar Lambret
Lille, Nord, France, 59000