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 : Unknown
Verified September 2017 by Institut Bergonié.
Recruitment status was: Recruiting
First Posted : June 19, 2013
Last Update Posted : October 2, 2017
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:
- Deepening trance
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)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Other: general anesthésia
- Evaluating the evolution of cognitive function in patients treated with surgery for breast cancer according to the type of anesthesia chosen by the patient [ Time Frame: at time of surgery ]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.
- Assess patient characteristics according to the type of anesthesia used [ Time Frame: 1 year ]
Assess patient characteristics (physiological, psychological and sociocultural) according to the type of anesthesia used, to identify characteristics predictive of choice of hypnosedation.
Depending on the type of anesthesia, evaluated before and after surgery: pain, anxiety level and patient satisfaction with regard to the anesthetic technique.
- Depending on the type of anesthesia: pain, anxiety level and patient satisfaction with regard to the anesthetic technique. [ Time Frame: at time of surgery ]Pain and patient satisfaction will be evaluated by a numerical scale and emotional state by the HAD scale.
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
|Contact: COLOMBANI Sylvie, MDemail@example.com|
|Contact: MATHOULIN PELISSIER Simone, PU-PHfirstname.lastname@example.org|
|Centre Paul Strauss||Recruiting|
|Strasbourg, Alsace, France, 67000|
|Contact: DAHLET Christian, MD|
|Principal Investigator: DAHLET Christian, MD|
|Bordeaux, Aquitaine, France, 33000|
|Contact: COLOMBANI Sylvie, MD email@example.com|
|Principal Investigator: COLOMBANI Sylvie, MD|
|Centre Oscar Lambret||Recruiting|
|Lille, Nord, France, 59000|
|Contact: HAMDANI Agnès, MD|
|Principal Investigator: HAMDANI Agnès, MD|
|Study Chair:||COLOMBANI Sylvie, MD||Institut Bergonié|