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Clinical Trials/NCT01993771
NCT01993771
Completed
Not Applicable

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

Parc de Salut Mar1 site in 1 country25 target enrollmentSeptember 2013
ConditionsBreast Surgery

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Surgery
Sponsor
Parc de Salut Mar
Enrollment
25
Locations
1
Primary Endpoint
Bilateral BIS values from frontal and parietal areas.
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
October 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Parc de Salut Mar
Responsible Party
Principal Investigator
Principal Investigator

Juan Luis Fernández Candil

MD

Parc de Salut Mar

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Bilateral BIS values from frontal and parietal areas.

Time Frame: 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 Outcomes

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

Study Sites (1)

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