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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01880541
Recruitment Status : Completed
First Posted : June 19, 2013
Results First Posted : March 4, 2022
Last Update Posted : March 4, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

Study Description
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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.


Condition or disease Intervention/treatment Phase
Patients With Breast Cancer and Breast Surgery Requiring Other: hypnosedation Other: general anesthésia Not Applicable

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.

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: hypnosedation
hypnosedation
 Other: hypnosedation
hypnosedation
general anesthesia
general anesthesia
 Other: general anesthésia
general anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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France
Centre Paul Strauss
Strasbourg, Alsace, France, 67000
Institut Bergonié
Bordeaux, Aquitaine, France, 33000
Centre Oscar Lambret
Lille, Nord, France, 59000
Sponsors and Collaborators
Institut Bergonié
Investigators
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Study Chair: COLOMBANI Sylvie, MD Institut Bergonié
  Study Documents (Full-Text)

Documents provided by Institut Bergonié:
Study Protocol  [PDF] November 5, 2009
No Statistical Analysis Plan (SAP) exists for this study.

More Information
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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
Keywords provided by Institut Bergonié:
Patients with breast cancer and breast surgery requiring
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs