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

Breast Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01993771
• Other study ID #: HOLOBIS
• Status: Completed
• Phase: N/A
• First received: September 20, 2013
• Last updated: March 29, 2016
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: March 2016
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Surgery

Intervention

Procedure:
• Surgery with general anaesthesia.

• Raw EEG

Locations

Country	Name	City	State
Spain	Hospital del Mar	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Parc de Salut Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	EEG changes at LOC (loss of consciousness) and ROC (recovery of consciousness).		Changes will be evaluated at induction and emergence.	No