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

NCT ID: NCT01993771

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Breast Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Males and females with alopecia

Males and females with alopecia scheduled for general anaesthesia.

Surgery with general anaesthesia.

Intervention Type PROCEDURE

Raw EEG

Intervention Type PROCEDURE

Interventions

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Surgery with general anaesthesia.

Intervention Type PROCEDURE

Raw EEG

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Juan Luis Fernández Candil

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital del Mar

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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HOLOBIS

Identifier Type: -

Identifier Source: org_study_id

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