Relationship Between Bispectral Index, EEG Features, and Propofol Effect-site Concentration in Young and Elderly Patients.

NCT04774120 | Completed DMC FDA Drug

• 1 other identifier: 200726002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to describe the BIS values and electroencephalographic patterns during total intravenous anesthesia with propofol-remifentanyl, in patients from 18 to 85 years.

Conditions

Electroencephalography; Aging; Propofol; Depth of Anesthesia

Keywords

electroencephalography; bispectral index; propofol; alpha band; aging; burst suppression

Outcome Measures

Primary Outcomes (1)

• BIS values at which EEG patterns appears during induction of anesthesia with propofol.

  BIS values correlated to specific EEG patterns (frequency bands, complexity measures and burst suppression)

  From induction of anesthesia until suppression rate appears, an average of 15 minutes.

Secondary Outcomes (6)

• Propofol effect-site concentration (µg/ml) required to observe specific EEG patterns

  From induction of anesthesia until loss of consciousness, an average of 15 minutes.

• Propofol effect-site concentration (µg/ml) required to achieve loss of consciousness

  From Induction of anesthesia until suppression rate appears, an average of 15 minutes.

• BIS values at loss of consciousness

  From Induction of anesthesia until suppression rate appears, an average of 15 minutes.

• Percentage of time with BIS values between 40-60 and out of this range.

  From induction of anesthesia until patient's extubation, an average of 90 minutes.

• Time to achieve loss of consciousness

  From Induction of anesthesia until loss of consciousness, an average of 10 minutes.

Study Arms (2)

Young Patients (Patients aged 18 to 65 years.)

Propofol infusion rate will be started at 20-25 mg/kg/hr until SR achieved. Then restarted at half of the initial rate. Maintenance of anesthesia will be guided by Sedline Monitor to maintain an alpha band present in the spectrogram and SEF95 between 8-12 Hz. BIS monitor will be covered. Both EEG signals (Sedline and BIS) will be registered simultaneously until the patient's extubation.

Drug: Propofol

Elderly patients (Patients aged 65 to 85 years. )

Propofol infusion rate will be started at 15-20 mg/kg/hr until SR achieved. Then restarted at half of the initial rate. Maintenance of anesthesia will be guided by Sedline Monitor to maintain an alpha band present in the spectrogram and SEF95 between 8-12 Hz. BIS monitor will be covered. Both EEG signals (Sedline and BIS) will be registered simultaneously until the patient's extubation.

Drug: Propofol

Interventions

Propofol DRUG

Propofol will be started at a rate of 15-20 mg/kg/hr in patients \>65 years and 20-25 mg/kg/hr in younger patients (\<65 years) until a suppression rate (SR) is achieved. If not, can be increased by 5 mg/kg/hr every 5 minutes up to 25 mg/kg/hr in the elderly group and 30 mg/kg/hr in the younger group or after 15 minutes have passed. When the SR appears, propofol infusion will be stopped. Then restarted at half of the initial rate. Maintenance of anesthesia will be guided by Sedline Monitor to maintain an alpha band present in the spectrogram and SEF95 between 8-12 Hz. BIS monitor will be covered. Both EEG signals (Sedline and BIS) will be registered simultaneously until the patient's extubation.

Also known as: Diprivan, Propoven

Elderly patients (Patients aged 65 to 85 years. ); Young Patients (Patients aged 18 to 65 years.)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), 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. Formal characterization of the dynamic relationship between propofol concentrations at the effect site (Ce), spectral power, and BIS values may provide clinically relevant information to design propofol dose schemes in young and elderly patients.

You may qualify if:

• Adult patients 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 or history of cognitive impairment.
• 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

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

Related Publications (1)

• Purdon PL, Pavone KJ, Akeju O, Smith AC, Sampson AL, Lee J, Zhou DW, Solt K, Brown EN. The Ageing Brain: Age-dependent changes in the electroencephalogram during propofol and sevoflurane general anaesthesia. Br J Anaesth. 2015 Jul;115 Suppl 1(Suppl 1):i46-i57. doi: 10.1093/bja/aev213.

  PMID: 26174300 BACKGROUND

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Daniela Muñoz, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: March 1, 2021
• Study Start: December 11, 2020
• Primary Completion: March 30, 2021
• Study Completion: May 30, 2021
• Last Updated: March 16, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)