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Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol

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ClinicalTrials.gov Identifier: NCT03195530
Recruitment Status : Terminated (Out of funding, no differences between groups)
First Posted : June 22, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:

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.


Condition or disease Intervention/treatment
Anesthesia Drug: Propofol

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.


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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol, According to the Characteristic Electroencephalographic Pattern
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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)

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): NCT03195530


Locations
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Chile
Division de Anestesia - Pontificia Universidad Catolica de Chile
Santiago, Region Metropolitana, Chile, 8330024
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile

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Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03195530     History of Changes
Other Study ID Numbers: 161207002
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anesthetics
Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General