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

Completed
Conditions
Breast Surgery
Interventions
Procedure: Surgery with general anaesthesia.
Procedure: Raw EEG
Registration Number
NCT01993771
Lead Sponsor
Parc de Salut Mar
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Males and females with alopeciaRaw EEGMales and females with alopecia scheduled for general anaesthesia.
Males and females with alopeciaSurgery with general anaesthesia.Males and females with alopecia scheduled for general anaesthesia.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
EEG changes at LOC (loss of consciousness) and ROC (recovery of consciousness).Changes will be evaluated at induction and emergence.

Trial Locations

Locations (1)

Hospital del Mar

🇪🇸

Barcelona, Spain

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