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

Status

Terminated

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

12

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

    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 8330024
        • Division de Anestesia - Pontificia Universidad Catolica de Chile

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Elderly patients
Patients over 65 years, scheduled to general surgery, requiring general anesthesia
Induction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction

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
To describe the BIS values correlated to specific EEG patterns
Induction of anesthesia

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.
Induction of anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 (Actual)

May 1, 2017

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

June 20, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

April 11, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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