Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID06237101

Influence of Remifentanil Concentrations on Burst Suppression Rate During Propofol Anesthesia in Adults Undergoing Elective Surgery

Led by University of Chile · Updated on 2025-11-20

20

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of remifentanil on the generation of burst suppression by propofol in adult patients aged 18 to 60 years undergoing elective low or intermediate risk surgery. The study focuses on whether different concentrations of remifentanil can influence the propofol concentration needed to produce burst suppression, a specific pattern seen in brain activity during anesthesia. Participants will be classified under American Society of Anesthesiology (ASA) I or II. Participants will receive general anesthesia with sequential administration of remifentanil and propofol. Initially, remifentanil will be given to reach a target concentration, followed by propofol infusion until loss of consciousness (LOC). After LOC and intubation, remifentanil doses will be adjusted randomly to medium or high concentrations while propofol doses vary to observe burst suppression generation. The protocol includes several phases of adjusting drug concentrations and maintaining hemodynamics with support drugs as needed. During the study, participants will have continuous monitoring including frontal EEG to record brain activity, blood pressure, and drug dosage. Loss of consciousness will be checked every 30 seconds during induction. Researchers will measure the propofol concentration at which burst suppression occurs and at LOC, along with blood pressure and doses of medications used to maintain stability. The total study duration per participant covers the anesthesia period with follow-up during surgery as per protocol requirements.

CONDITIONS

Brief Title

Remifentanil Effect on Burst Suppression Ratio

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 to 60 years
  • American Society of Anesthesiology (ASA) classification I or II
  • Scheduled for elective low or intermediate risk surgery
Not Eligible

You will not qualify if you...

  • Neurological disease
  • Psychiatric disease
  • Use of psychoactive drugs or opioids
  • Altered basal state of consciousness
  • Allergy to propofol
  • Body mass index greater than 35 kg/m2
  • Pre-existing renal, cardiac, or hepatic dysfunction
  • Patient refusal to participate

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 40 minutes

Participants receive remifentanil and propofol anesthesia during elective surgery. The remifentanil dose is adjusted to study its effect on burst suppression during propofol anesthesia, with monitoring of EEG and hemodynamics throughout approximately 40 minutes of anesthesia induction and dosing adjustments.

1 visit (in-person, during surgery)

Trial Site Locations

Total: 2 locations

1

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

Santiago, RM, Chile, 7690306

Actively Recruiting

2

Hospital Clinico de la Universidad de Chile

Santiago, RM, Chile, 7690306

Actively Recruiting

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Research Team

A

Antonello Penna, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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