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Completed

NCT Number: NCT07237477

Reevaluation Prediction of the Effect Site Propofol Eleveld Model Using Slow and Fast Induction

Patients ASA1-2, 18 to 70 years old, scheduled for elective surgery with personal conset to participate, will be randomised into two groups using different induction mode. TCI effect site mode induction or TCI plasma mode induction both using the Elevelt PKPD propofol model. Standard monitoring (EKG, SaO2, PCo2et, NIAP), and Conox/ and or BIS EEG monitor to evaluate the prediction.

The model's prediction will be compared with values provided by the Conox/BIS index for both groups and between them. The study will be conducted during the 20 minutes after Loss of responsiveness.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Base san José de Osorno

Osorno, Los Lagos Region, 5290000, Chile

About this study

Patients aged 18 to 70 years will be included. Patients allergic to propofol are excluded. Eleveld's PKPD model for propofol includes covariates for adjustment in administration with target-controlled infusion pumps. Induction to the site of effect will be performed using EC60 for each age, while slow induction will use the target plasma modality, starting at a target of 3 ug/ml and increasing by 0.5 ug/ml every 3 minutes until loss of consciousness. This is defined as the loss of response to voice and shoulder tap. The 20 minutes following loss of consciousness will be evaluated.

Biometric and gender characteristics of both groups, concomitant pathologies, and surgical times will be compared.

The temporal evolution of the propofol effect site predicted by the Eleveld model will be compared between the two types of induction using EEG (CONOX or BIS). To obtain the EEG index prediction by Eleveld it will be use the Tiva trainer software 2.0, simulating the evolution of the kinetics and effect site calculated by Eleveld in the infudion TCI pumps.

It is estimated that 20 patients per group are required to find a 20% difference in predicted versus actual EEG index with 90% power.

Statistical methods:

  • Data analysis tool: Stata 10 software
  • Statistics
  • Summary: Mean (central tendency) and standard deviation (dispersion)
  • Association: Student's t-test for continuous quantitative variables and Fisher's exact test for dichotomous variables.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients ASA 1-2 scheduled for elective surgery, Exclusion Criteria: patients with psychiatric disorders, allergic to propofol, not giving their consent to participate

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Treatment and study plan

Evaluation of the prediction of from the propofol PKPD model including in TCI pumps using fast (Effect site mode TCI) or slow (plasma TCI mode) induction

Drug

Using TCI technology and EEG monitoring (CONOX) we will induce loss of responsiveness using the fast induction (Group 1) or slow induction (Group 2) and compare the prediction of the effect site model (PD) in each type of induction.

Primary outcomes

  1. Prediction of the efect site propofol Eleveld model

    Time frame: The data will be retrieved directly from the infusion pumps and EEGs up to 20 minutes after the loss of clinical consciousness.

    The comparison betwen predicted and actual CONOX/BIS index will be made in two scenario: TCI effect site mode induction versus TCI plasma mode induction

Sponsors and collaborators

Lead sponsor

Pablo O. Sepulveda

Other

Registry information

Official study title

Comparison of the Site Effect Model Prediction and BIS Predicted by Eleveld for Propofol in Slow and Rapid Inductions

Acronym: fast or slow E

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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