- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195530
Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol
Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol, According to the Characteristic Electroencephalographic Pattern
A correlation between the bispectral index values and electroencephalographic patterns at the loss of consciousness (LOC) when using propofol in elderly patients, has not been determined.
Our aim is to describe the BIS values and the power of the alpha band in the electroencephalography in elderly patients, at the LOC moment.
Study Overview
Detailed Description
Propofol is an anesthetic drug regularly used in elderly patients requiring anesthesia. The electroencephalographic pattern recognized when propofol is administered, is different to the pattern obtained in younger patients. Both groups presents an alpha and slow bands, but they differ in the intensity of the signal. Younger patients presents more intense electroencephalographic bands than older patients.
Bispectral index (BIS) is a clinical indicator used to evaluate the depth of anesthesia. A correlation between this indicator and the power of electroencephalographic bands has not been determined.
We will describe the LOC moment of elderly patients receiving propofol as anesthetic for general surgery, with the EEG characteristic bands and the BIS value obtained at that moment. The BIS values related to the EEG characteristic bands can be described, to correlate the actual indicators of depth of anesthesia with new parameters.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Region Metropolitana
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Santiago, Region Metropolitana, Chile, 8330024
- Division de Anestesia - Pontificia Universidad Catolica de Chile
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Elderly patients scheduled for surgery are an understudied population. Incidence of postoperative delirium and other complications can be related to changes in cerebral dynamics under anesthesia, with effects observed even after the use of anesthetics agents.
To characterize changes in EEG patterns under the induction of anesthesia, can give new information to understand the physiology of the elderly brain under anesthesia.
Description
Inclusion Criteria:
- Patients over 65 years
- Scheduled for elective surgery requiring general anesthesia
- American Society of Anesthesiology (ASA) Score I or II
Exclusion Criteria:
- Patients with neurological diseases
- Requiring the use of two or more drugs affecting Central nervous system
- History of drugs or alcohol abuse
- Body mass index over 35 kg/m^2
- Propofol allergy
- Cardiac congestive failure
- History of coronary syndrome
- Minimental test altered (Score under 24 points)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elderly patients
Patients over 65 years, scheduled to general surgery, requiring general anesthesia
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Induction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BIS values at which EEG patterns (Slow and alpha bands) appears in elderly population using propofol
Time Frame: Induction of anesthesia
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To describe the BIS values correlated to specific EEG patterns
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Induction of anesthesia
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Propofol concentration required to observe specific EEG patterns
Time Frame: Induction of anesthesia
|
To describe the serum propofol concentrations required for induction of anesthesia, to observe alpha and slow bands at the EEG.
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Induction of anesthesia
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 161207002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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