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

Terminated

• Conditions: Anesthesia
• Interventions: Drug: Propofol

• Registration Number: NCT03195530
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-22
• Primary Completion: 2018-01-31
• Study Completion: 2018-03-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-09
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Elderly patients	Propofol	Patients over 65 years, scheduled to general surgery, requiring general anesthesia

Primary Outcome Measures

Name	Time	Method
BIS values at which EEG patterns (Slow and alpha bands) appears in elderly population using propofol	Induction of anesthesia	To describe the BIS values correlated to specific EEG patterns

Secondary Outcome Measures

Name	Time	Method
Propofol concentration required to observe specific EEG patterns	Induction of anesthesia	To describe the serum propofol concentrations required for induction of anesthesia, to observe alpha and slow bands at the EEG.

Trial Locations

Locations (1)

Division de Anestesia - Pontificia Universidad Catolica de Chile; 🇨🇱 Santiago, Region Metropolitana, Chile