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

Assessment of Cognitive Function After Surgery in Two Types of Anesthesia (General Anesthesia Hypnosedation or Traditional) in Patients Operated for Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Patients With Breast Cancer and Breast Surgery Requiring
• Intervention / Treatment: Other: hypnosedation; Other: general anesthésia

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alsace
    • Strasbourg, Alsace, France, 67000
      • Centre Paul Strauss
  • Aquitaine
    • Bordeaux, Aquitaine, France, 33000
      • Institut Bergonie
  • Nord
    • Lille, Nord, France, 59000
      • Centre Oscar Lambret

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: general anesthesia	Other: general anesthésia; general anesthesia
Experimental: hypnosedation	Other: hypnosedation; hypnosedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Cognitive Impairment	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)	on the 7th day following surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Cognitive Impairment	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)	1 month after surgery

Collaborators and Investigators

• Sponsor: Institut Bergonié
• Investigators: Study Chair: COLOMBANI Sylvie, MD, Institut Bergonie

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: November 6, 2012
• First Submitted That Met QC Criteria: June 14, 2013
• First Posted (Estimate): June 19, 2013

Study Record Updates

• Last Update Posted (Actual): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Patients with breast cancer and breast surgery requiring
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: IB2009-71