Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Unknown
Verified September 2017 by Institut Bergonié.
Recruitment status was:  Recruiting
First Posted : June 19, 2013
Last Update Posted : October 2, 2017
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: hypnosedation
hypnosedation
 Other: hypnosedation
hypnosedation
general anesthesia
general anesthesia
 Other: general anesthésia
general anesthesia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Contacts
Layout table for location contacts
Contact: COLOMBANI Sylvie, MD s.colombani@bordeaux.unicancer.fr
Contact: MATHOULIN PELISSIER Simone, PU-PH s.mathoulin@bordeaux.unicancer.fr

Locations
Layout table for location information
France
Centre Paul Strauss Recruiting
Strasbourg, Alsace, France, 67000
Contact: DAHLET Christian, MD         
Principal Investigator: DAHLET Christian, MD         
Institut Bergonié Recruiting
Bordeaux, Aquitaine, France, 33000
Contact: COLOMBANI Sylvie, MD       s.colombani@bordeaux.unicancer.fr   
Principal Investigator: COLOMBANI Sylvie, MD         
Centre Oscar Lambret Recruiting
Lille, Nord, France, 59000
Contact: HAMDANI Agnès, MD         
Principal Investigator: HAMDANI Agnès, MD         
Sponsors and Collaborators
Institut Bergonié
Investigators
Layout table for investigator information
Study Chair: COLOMBANI Sylvie, MD Institut Bergonié
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Registre des essais cliniques de l'INCa  This link exits the ClinicalTrials.gov site

Layout table for additonal information
Responsible Party: Institut Bergonié
ClinicalTrials.gov Identifier: NCT01880541     History of Changes
Other Study ID Numbers: IB2009-71
First Posted: June 19, 2013    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017
Keywords provided by Institut Bergonié:
Patients with breast cancer and breast surgery requiring
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs