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

Anesthesia Clinical Trial

Official title:

Bispectral Index (BIS) Values Required for an Adequate Depth of Anesthesia in Elderly Patients Using Propofol, According to the Characteristic Electroencephalographic Pattern

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03195530
• Other study ID #: 161207002
• Status: Terminated
• First received: June 20, 2017
• Last updated: April 9, 2018
• Start date: May 1, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2018
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol
Induction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction

Locations

Country	Name	City	State
Chile	Division de Anestesia - Pontificia Universidad Catolica de Chile	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BIS values at which EEG patterns (Slow and alpha bands) appears in elderly population using propofol	To describe the BIS values correlated to specific EEG patterns	Induction of anesthesia
Secondary	Propofol concentration required to observe specific EEG patterns	To describe the serum propofol concentrations required for induction of anesthesia, to observe alpha and slow bands at the EEG.	Induction of anesthesia