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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
Sponsor:
Information provided by (Responsible Party):
Institut Bergonié

Tracking Information
First Submitted Date  ICMJE November 6, 2012
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date October 2, 2017
Study Start Date  ICMJE December 2010
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01880541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer
Official Title  ICMJE Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Patients With Breast Cancer and Breast Surgery Requiring
Intervention  ICMJE
  • Other: hypnosedation
    hypnosedation
  • Other: general anesthésia
    general anesthesia
Study Arms  ICMJE
  • Experimental: hypnosedation
    hypnosedation
    Intervention: Other: hypnosedation
  • general anesthesia
    general anesthesia
    Intervention: Other: general anesthésia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 14, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01880541
Other Study ID Numbers  ICMJE IB2009-71
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Bergonié
Study Sponsor  ICMJE Institut Bergonié
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: COLOMBANI Sylvie, MD Institut Bergonié
PRS Account Institut Bergonié
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP