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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

Tracking Information
First Submitted Date June 20, 2017
First Posted Date June 22, 2017
Last Update Posted Date April 11, 2018
Actual Study Start Date May 1, 2017
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 21, 2017)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 21, 2017)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol
Official Title Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol, According to the Characteristic Electroencephalographic Pattern
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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Anesthesia
Intervention Drug: Propofol
Induction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction
Study Groups/Cohorts Elderly patients
Patients over 65 years, scheduled to general surgery, requiring general anesthesia
Intervention: Drug: Propofol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 9, 2018)
12
Original Estimated Enrollment
 (submitted: June 21, 2017)
19
Actual Study Completion Date March 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Chile
Removed Location Countries  
 
Administrative Information
NCT Number NCT03195530
Other Study ID Numbers 161207002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Pontificia Universidad Catolica de Chile
Study Sponsor Pontificia Universidad Catolica de Chile
Collaborators Not Provided
Investigators Not Provided
PRS Account Pontificia Universidad Catolica de Chile
Verification Date April 2018