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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01880541
Other study ID # IB2009-71
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 2010
Est. completion date December 2017

Study information

Verified date December 2021
Source Institut Bergonié
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2017
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hypnosedation
hypnosedation
general anesthésia
general anesthesia

Locations

Country Name City State
France Institut Bergonié Bordeaux Aquitaine
France Centre Oscar Lambret Lille Nord
France Centre Paul Strauss Strasbourg Alsace

Sponsors (1)

Lead Sponsor Collaborator
Institut Bergonié

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
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) on the 7th day following surgery
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) 1 month after surgery