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Monitoring of Anaesthesic Depth in the Cerebral Cortex Using Bispectral Bilateral System.

Monitoring of Anaesthetic Depth at Different Locations in the Cerebral Cortex Using Bispectral Bilateral System

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01993771
Enrollment
25
Registered
2013-11-25
Start date
2013-09-30
Completion date
2015-10-31
Last updated
2016-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Surgery

Brief summary

This is a prospective, observational study, aimed to establish changes of bispectral bilateral system in both cerebral hemispheres during a total intravenous anaesthesia during breast surgery in the woman. By placing two Bispectral bilateral sensors (BIS), one on both frontal lobes, and another on both parietal lobes, we wanted to evaluate differences between frontal and parietal areas, when the patient is awake and during the anaesthetic procedure.

Interventions

PROCEDURESurgery with general anaesthesia.
PROCEDURERaw EEG

Sponsors

Parc de Salut Mar
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Aged more than 18 years old. * Scheduled for general anaesthesia. * Agree to participate(signed inform consent).

Exclusion criteria

* Neurological disease. * Cognitive impairment. * Egg allergy. * Severe disease or condition that could potentially interfere with interpretation of tests.

Design outcomes

Primary

MeasureTime frame
Bilateral BIS values from frontal and parietal areas.Bilateral BIS values will be taken at baseline, anaesthetic induction, endotracheal intubation, skin incision, mantenance of anaesthesia and in emergence from anaesthesia ( 3 hours as a maximum from baseline to emergence).

Secondary

MeasureTime frame
EEG changes at LOC (loss of consciousness) and ROC (recovery of consciousness).Changes will be evaluated at induction and emergence.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026