Clinical trial NCT01880541: Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer
Official title: Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Breast Cancer and Breast Surgery Requiring
Keywords: Patients with breast cancer and breast surgery requiring
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 cognitive disorders can range from simple reversible confusion (26%) with postoperative cognitive dysfunction without actual recovery (10%).

The hypnosedation is an ancient technique of anesthesia expanding its effects on cognitive function remain to this day unknown, but appear promising.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence of Cognitive Impairment
timeFrame: on the 7th day following surgery
Secondary outcomes:
measure: Presence of Cognitive Impairment
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Centre Paul Strauss
state: Alsace
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
city: Lille
country: France
facility: Centre Oscar Lambret
state: Nord
Study officials:
affiliation: Institut Bergonié
name: COLOMBANI Sylvie, MD
role: STUDY_CHAIR
References: