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

NCT01880541 | Completed Results DMC

• 1 other identifier: IB2009-71
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

Patients With Breast Cancer and Breast Surgery Requiring

Keywords

Patients with breast cancer and breast surgery requiring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Presence of Cognitive Impairment

  1 month after surgery

Study Arms (2)

hypnosedation

EXPERIMENTAL

hypnosedation

Other: hypnosedation

general anesthesia

OTHER

general anesthesia

Other: general anesthésia

Interventions

hypnosedation OTHER

hypnosedation

hypnosedation

general anesthésia OTHER

general anesthesia

general anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Bergonié: lead

Study Sites (3)

Centre Paul Strauss

Strasbourg, Alsace, 67000, France

Location

Institut Bergonié

Bordeaux, Aquitaine, 33000, France

Location

Centre Oscar Lambret

Lille, Nord, 59000, France

Location

MeSH Terms

Interventions

Hypnosis, Anesthetic

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Pr Simone Mathoulin-Pélissier
• Organization: Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

s.mathoulin@bordeaux.unicancer.fr

0556333333

Study Officials

• COLOMBANI Sylvie, MD

  Institut Bergonié

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2012
• First Posted: June 19, 2013
• Study Start: December 1, 2010
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 4, 2022
• Results First Posted: March 4, 2022

Record last verified: 2021-12

Locations

FR (3)