N/A
N=30
Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer
Patients With Breast Cancer and Breast Surgery Requiring
Bottom Line
View on ClinicalTrials.gov: NCT01880541 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Mar 2022
Primary outcome: Primary: Presence of Cognitive Impairment — 29.5; 29 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- hypnosedation (Other); general anesthésia (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Institut Bergonié
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Cognitive Impairment |
29.5; 30 | — |
| SECONDARY Presence of Cognitive Impairment |
29.5; 30 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01880541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.