Skip to main content
OpenTrials
Completed

NCT Number: NCT01993771

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital del Mar

Barcelona, 08026, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgery with general anaesthesia.

Procedure

Raw EEG

Procedure

Primary outcomes

  1. 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

  1. EEG changes at LOC (loss of consciousness) and ROC (recovery of consciousness).

    Time frame: Changes will be evaluated at induction and emergence.

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2013
Registry last updated
Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.