- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01993771
Monitoring of Anaesthesic Depth in the Cerebral Cortex Using Bispectral Bilateral System.
March 29, 2016 updated by: Juan Luis Fernández Candil, Parc de Salut Mar
Monitoring of Anaesthetic Depth at Different Locations 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
25
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Barcelona, Spain, 08026
- Hospital Del Mar
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with alopecia scheduled for general anaesthesia.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Males and females with alopecia
Males and females with alopecia scheduled for general anaesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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).
|
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
Outcome Measure |
Time Frame |
---|---|
EEG changes at LOC (loss of consciousness) and ROC (recovery of consciousness).
Time Frame: Changes will be evaluated at induction and emergence.
|
Changes will be evaluated at induction and emergence.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
September 20, 2013
First Submitted That Met QC Criteria
November 20, 2013
First Posted (Estimate)
November 25, 2013
Study Record Updates
Last Update Posted (Estimate)
March 30, 2016
Last Update Submitted That Met QC Criteria
March 29, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOLOBIS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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