NCT01993771

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

1.9 years

First QC Date

September 20, 2013

Last Update Submit

March 29, 2016

Conditions

Breast Surgery

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (1)

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

    Changes will be evaluated at induction and emergence.

Study Arms (1)

Males and females with alopecia

Males and females with alopecia scheduled for general anaesthesia.

Procedure: Surgery with general anaesthesia.Procedure: Raw EEG

Interventions

Surgery with general anaesthesia.PROCEDURE
Males and females with alopecia
Raw EEGPROCEDURE
Males and females with alopecia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with alopecia scheduled for general anaesthesia.

You may qualify if:

  • Aged more than 18 years old.
  • Scheduled for general anaesthesia.
  • Agree to participate(signed inform consent).

You may not qualify if:

  • Neurological disease.
  • Cognitive impairment.
  • Egg allergy.
  • Severe disease or condition that could potentially interfere with interpretation of tests.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08026, Spain

Location

MeSH Terms

Interventions

Surgical Procedures, OperativeAnesthesia, General

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 20, 2013

First Posted

November 25, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations

ES(1)