Trial Outcomes & Findings for Assessment of Cognitive Function After Surgery in Two Types of Anesthesia in Patients Operated for Breast Cancer (NCT NCT01880541)

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

on the 7th day following surgery

Results posted on

2022-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	Hypnosedation hypnosedation hypnosedation: hypnosedation	General Anesthesia general anesthesia general anesthésia: general anesthesia
Overall Study STARTED	10	20
Overall Study COMPLETED	10	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hypnosedation n=10 Participants hypnosedation hypnosedation: hypnosedation	General Anesthesia n=20 Participants general anesthesia general anesthésia: general anesthesia	Total n=30 Participants Total of all reporting groups
Age, Continuous	50.2 years STANDARD_DEVIATION 16.1 • n=10 Participants	57.2 years STANDARD_DEVIATION 11.4 • n=20 Participants	54.9 years STANDARD_DEVIATION 13.3 • n=30 Participants
Sex: Female, Male Female	10 Participants n=10 Participants	20 Participants n=20 Participants	30 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	10 participants n=10 Participants	20 participants n=20 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: on the 7th day following surgery

Population: Participants who completed the questionnaire

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)

Outcome measures

Outcome measures
Measure	Hypnosedation n=10 Participants hypnosedation hypnosedation: hypnosedation	General Anesthesia n=19 Participants general anesthesia general anesthésia: general anesthesia
Presence of Cognitive Impairment	29.5 score on a scale Interval 29.0 to 30.0	29 score on a scale Interval 29.0 to 30.0

SECONDARY outcome

Timeframe: 1 month after surgery

Population: Participants who completed the questionnaire

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)

Outcome measures

Outcome measures
Measure	Hypnosedation n=10 Participants hypnosedation hypnosedation: hypnosedation	General Anesthesia n=18 Participants general anesthesia general anesthésia: general anesthesia
Presence of Cognitive Impairment	29.5 score on a scale Interval 29.0 to 30.0	30 score on a scale Interval 29.0 to 30.0

Adverse Events

Hypnosedation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

General Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pr Simone Mathoulin-Pélissier

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: 0556333333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place