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

NCT03195530 | Terminated DMC

• 1 other identifier: 161207002
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Propofol concentration required to observe specific EEG patterns

  Induction of anesthesia

Study Arms (1)

Elderly patients

Patients over 65 years, scheduled to general surgery, requiring general anesthesia

Drug: Propofol

Interventions

Propofol DRUG

Induction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction

Elderly patients

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• Patients over 65 years
• Scheduled for elective surgery requiring general anesthesia
• American Society of Anesthesiology (ASA) Score I or II

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Division de Anestesia - Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: May 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: March 31, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)