Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer

NCT ID: NCT01880541

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2017-12-31

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.

Conditions

Patients With Breast Cancer and Breast Surgery Requiring

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

hypnosedation

hypnosedation

Group Type: EXPERIMENTAL

hypnosedation

Intervention Type: OTHER

hypnosedation

general anesthesia

general anesthesia

Group Type: OTHER

general anesthésia

Intervention Type: OTHER

general anesthesia

Interventions

hypnosedation

hypnosedation

Intervention Type: OTHER

general anesthésia

general anesthesia

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Bergonié

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

COLOMBANI Sylvie, MD

Role: STUDY_CHAIR

Institut Bergonié

Locations

Centre Paul Strauss

Strasbourg, Alsace, France

Institut Bergonié

Bordeaux, Aquitaine, France

Centre Oscar Lambret

Lille, Nord, France

Countries

France

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

IB2009-71

Identifier Type: -

Identifier Source: org_study_id