Recruiting

Remifentanil's Effect on EEG Burst Suppression During Anesthesia

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Study Aim

This study aims to examine how remifentanil affects brain activity patterns, specifically burst suppression, during anesthesia in individuals receiving propofol.

What is being tested

High dose of remifentanil

+ Medium dose of remifentanil

Drug
Who is being recruted

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Interventional
Study Start: March 2024
See protocol details

Summary

Principal SponsorUniversity of Chile
Study ContactAntonello Penna, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2024

Actual date on which the first participant was enrolled.

This study aims to examine how different levels of the drug Remifentanil affect brain activity in patients undergoing general anesthesia with Propofol. It specifically looks at a phenomenon called burst suppression, which can be seen in brain waves during deep anesthesia. The study is important because understanding how these drugs interact can help improve anesthesia practices, ensuring patients remain safely unconscious during surgery while minimizing potential side effects. The study targets individuals who require surgery under general anesthesia, addressing the need to optimize drug doses for better patient care. Participants in the study will receive anesthesia in a controlled hospital setting. Initially, an intravenous cannula is placed to administer the drugs, and participants will have their brain activity monitored using an EEG device. The study involves adjusting the doses of Remifentanil and Propofol and recording the resulting changes in brain activity. Participants will be intubated after losing consciousness, and the drug levels will be varied according to the study's design. Throughout the procedure, usual medications will be used to maintain stable heart and blood pressure levels. The study does not mention specific risks or benefits, but it is focused on improving the understanding of anesthesia effects on brain activity.

Official TitleInfluence of Variable Plasma Concentrations of Remifentanil on Burst Suppression (BS) Event Rate in Electroencephalographic (EEG) Recordings of Human Subjects Undergoing Total Intravenous General Anesthesia (TIVA) Under Propofol
NCT06237101
Principal SponsorUniversity of Chile
Study ContactAntonello Penna, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: * American Society of Anesthesiology I or II * Elective surgery of low or intermediate risk Exclusion Criteria: * Neurological disease * Psychiatric disease * Use of psychoactive drugs or opioids * Altered basal state of consciousness * Allergy to propofol * Body mass index \> 35 kg/m2 * Pre-existing renal, cardiac and/or hepatic dysfunction * Patient's refusal to participate

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Propofol concentration which generate burst suppression at high dose of remifentanil

Group II

Active Comparator
Propofol concentration which generate burst suppression at medium dose of remifentanil

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile

Santiago, ChileOpen Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile in Google Maps
Recruiting

Hospital Clinico de la Universidad de Chile

Santiago, Chile
Recruiting
2 Study Centers