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

• ClinicalTrials.gov Identifier: NCT01880541
• Recruitment Status: Unknown
• First Posted: June 19, 2013
• Last Update Posted: October 2, 2017
• Sponsor: Institut Bergonié
• Information provided by (Responsible Party): Institut Bergonié

Tracking Information

• First Submitted Date: November 6, 2012
• First Posted Date: June 19, 2013
• Last Update Posted Date: October 2, 2017
• Study Start Date: December 2010
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01880541 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Patients With Breast Cancer and Breast Surgery Requiring

Intervention

• Other: hypnosedation
  hypnosedation
• Other: general anesthésia
  general anesthesia

Study Arms

• Experimental: hypnosedation
  hypnosedation
  Intervention: Other: hypnosedation
• general anesthesia
  general anesthesia
  Intervention: Other: general anesthésia

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 14, 2013): 50
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2018
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01880541
• Other Study ID Numbers: IB2009-71
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Institut Bergonié
• Study Sponsor: Institut Bergonié
• Collaborators: Not Provided

Investigators

• Study Chair: COLOMBANI Sylvie, MD; Institut Bergonié

• PRS Account: Institut Bergonié
• Verification Date: September 2017