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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


N/A
18 Years
N/A
Open (Enrolling)
Female
Patients With Breast Cancer and Breast Surgery Requiring

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Trial Information

Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer


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 hospitals for specific surgical indications (surgery area). It is
commonly used in some hospitals.

The hypnosedation is little used in oncology

The hypnosedation is a hypnosis technique suitable for anesthesia, namely the one associated
with intravenous conscious sedation and local anesthesia hypnosis. This derived from medical
hypnosis Ericksoniene technique is divided into three stages:

1. induction

2. Deepening trance

3. Déhypnotisation.

This technique is currently being validated and used at national and international level, in
fact it is based on 500 references and appears in the national nomenclature of the Common
Classification of Medical Procedures in the code ANRP 001, states: hypnosis referred to
analgesic.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Evaluating the evolution of cognitive function in patients treated with surgery for breast cancer according to the type of anesthesia chosen by the patient

Outcome Description:

Evaluation of cognitive impairment in a series of neuropsychological tests validated : questionnaire for subjective cognitive complaint cognitive and memory test Grober and Buschke, attentional tests and tests of executive functions for cognitive objectives.

Outcome Time Frame:

at time of surgery

Safety Issue:

No

Principal Investigator

COLOMBANI Sylvie, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Bergonié

Authority:

France: National Security Agency of the drug and health product

Study ID:

IB2009-71

NCT ID:

NCT01880541

Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Patients With Breast Cancer and Breast Surgery Requiring
  • Patients with breast cancer and breast surgery requiring
  • Breast Neoplasms

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