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Dose-response Curves Between Propofol and Intraoperative Electroencephalographic Patterns

NCT04345926 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-04-28

No results posted yet for this study

Summary

In the world, 230 million surgeries are performed per year and a significant part is performed in patients over 65 years of age. These patients are more labile, especially from the neurocognitive point of view with a high risk to develop neurocognitive complications, such as postoperative delirium. Recent studies have linked this type of complication with an overdose of general anesthetics during surgery. For this reason, in recent years, the use of brain function monitors during the intraoperative period has been recommended to adapt the dosage of the drugs to each patient and thus to avoid overdosing of general anesthetics. However, to date, the available monitors that process the electroencephalographic signal are not able to adequately discriminate gradual changes in anesthetic depth. Also, no systematic studies have been performed that analyze changes that occur in the electroencephalogram (EEG) signal secondary to increases in complications from general anesthetics. Thus, the investigators design this study with the main aim to determine the changes in electroencephalographic patterns induced by a stepped increase of propofol until the burst suppression is reached.

Conditions

  • Propofol Overdose
  • EEG

Interventions

DRUG

Propofol

Stepped propofol concentration after 20 min of LOS

DEVICE

Electroencephalogram recording

Acquisition of EEG activity

Sponsors & Collaborators

  • University of Chile

    lead OTHER

Principal Investigators

  • Jose I Egaña, MD/PhD · University of Chile

  • Felipe Maldonado, MD · University of Chile

  • Rodrigo Gutierrez, MD/PhD · University of Chile

  • Antonello Penna, MD/PhD · University of Chile

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-16
Primary Completion
2020-02-26
Completion
2020-02-26
FDA Drug
Yes
FDA Device
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04345926 on ClinicalTrials.gov