Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993771
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Juan Luis Fernández Candil, 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.

Condition or disease Intervention/treatment
Breast Surgery Procedure: Surgery with general anaesthesia. Procedure: Raw EEG

Layout table for study information
Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring of Anaesthetic Depth at Different Locations in the Cerebral Cortex Using Bispectral Bilateral System
Study Start Date : September 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : October 2015

Group/Cohort Intervention/treatment
Males and females with alopecia
Males and females with alopecia scheduled for general anaesthesia.
Procedure: Surgery with general anaesthesia.
Procedure: Raw EEG



Primary Outcome Measures :
  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 Outcome Measures :
  1. EEG changes at LOC (loss of consciousness) and ROC (recovery of consciousness). [ Time Frame: Changes will be evaluated at induction and emergence. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with alopecia scheduled for general anaesthesia.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993771


Locations
Layout table for location information
Spain
Hospital del Mar
Barcelona, Spain, 08026
Sponsors and Collaborators
Parc de Salut Mar
Layout table for additonal information
Responsible Party: Juan Luis Fernández Candil, MD, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01993771    
Other Study ID Numbers: HOLOBIS
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 30, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs