Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer (HYPNOSEIN)
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ClinicalTrials.gov Identifier: NCT01880541 |
Recruitment Status :
Completed
First Posted : June 19, 2013
Results First Posted : March 4, 2022
Last Update Posted : March 4, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Patients With Breast Cancer and Breast Surgery Requiring | Other: hypnosedation Other: general anesthésia | Not Applicable |
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:
- induction
- Deepening trance
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 Start Date : | December 2010 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: hypnosedation
hypnosedation
|
Other: hypnosedation
hypnosedation |
general anesthesia
general anesthesia
|
Other: general anesthésia
general anesthesia |
- Presence of Cognitive Impairment [ Time Frame: 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)
- Presence of Cognitive Impairment [ Time Frame: 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)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01880541
France | |
Centre Paul Strauss | |
Strasbourg, Alsace, France, 67000 | |
Institut Bergonié | |
Bordeaux, Aquitaine, France, 33000 | |
Centre Oscar Lambret | |
Lille, Nord, France, 59000 |
Study Chair: | COLOMBANI Sylvie, MD | Institut Bergonié |
Documents provided by Institut Bergonié:
Responsible Party: | Institut Bergonié |
ClinicalTrials.gov Identifier: | NCT01880541 |
Other Study ID Numbers: |
IB2009-71 |
First Posted: | June 19, 2013 Key Record Dates |
Results First Posted: | March 4, 2022 |
Last Update Posted: | March 4, 2022 |
Last Verified: | December 2021 |
Patients with breast cancer and breast surgery requiring |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |