Patients With Breast Cancer and Breast Surgery Requiring
Conditions
Keywords
Patients with breast cancer and breast surgery requiring
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.
Interventions
OTHERhypnosedation
hypnosedation
OTHERgeneral anesthésia
general anesthesia
Sponsors
Institut Bergonié
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Cognitive Impairment | on the 7th day following surgery | Cognitive impairment is assessed using the MMSE questionnaire (MINI-MENTAL STATE EXAMINATION). the MMSE total score ranges from 0 (alteration of cognition) to 30 (no alteration) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Cognitive Impairment | 1 month after surgery | Cognitive impairment is assessed using the MMSE questionnaire (MINI-MENTAL STATE EXAMINATION) The MMSE total score ranges from 0 (alteration of cognition) to 30 (no alteration) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hypnosedation hypnosedation
hypnosedation: hypnosedation | 10 |
| General Anesthesia general anesthesia
general anesthésia: general anesthesia | 20 |
| Total | 30 |
Baseline characteristics
| Characteristic | General Anesthesia | Total | Hypnosedation |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 11.4 | 54.9 years STANDARD_DEVIATION 13.3 | 50.2 years STANDARD_DEVIATION 16.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment France | 20 participants | 30 participants | 10 participants |
| Sex: Female, Male Female | 20 Participants | 30 Participants | 10 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Presence of Cognitive Impairment
Cognitive impairment is assessed using the MMSE questionnaire (MINI-MENTAL STATE EXAMINATION). the MMSE total score ranges from 0 (alteration of cognition) to 30 (no alteration)
Time frame: on the 7th day following surgery
Population: Participants who completed the questionnaire
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hypnosedation | Presence of Cognitive Impairment | 29.5 score on a scale |
| General Anesthesia | Presence of Cognitive Impairment | 29 score on a scale |
Secondary
Presence of Cognitive Impairment
Cognitive impairment is assessed using the MMSE questionnaire (MINI-MENTAL STATE EXAMINATION) The MMSE total score ranges from 0 (alteration of cognition) to 30 (no alteration)
Time frame: 1 month after surgery
Population: Participants who completed the questionnaire
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hypnosedation | Presence of Cognitive Impairment | 29.5 score on a scale |
| General Anesthesia | Presence of Cognitive Impairment | 30 score on a scale |