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

NCT07237477 | Completed DMC FDA Drug

• 1 other identifier: Hospital Base San José Osoro
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia for Elective Surgery Patients; Anesthesia Brain Monitor; Pharmacodynamics

Keywords

Propofol, Eleveld model, induction flow, CONOX,

Outcome Measures

Primary Outcomes (1)

• Prediction of the efect site propofol Eleveld model

  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

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

Study Arms (2)

Group 1: the prediction of the Eleveld propofol model in effect site mode TCI induction

Patients ASA 1-2, 18 to 70 years, will be induced using propofol TCI in effect site mode EC60 of the Eleveld PKPD model and compared with the EEG CONOX behavior, If lost of responsiveness (LOR) was not reached, we climb up 0,5 ug/ml every 3 min. At LOR calculated effect site concentration will be used as reference to mantain anesthesia level.

Drug: 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

Group 2: the prediction of the Eleveld propofol model in TCI plasma mode

Patients ASA1-2, 18-70 years, scheduled for elective surgery longer than 1 hour. Induced with TCI plasma mode using the Eleveld PKPD model. The infusion will begin using a target plasma of 3 ug/ml, and scale every 3 minutes in 0,5 ug/ml until Loss of responsiveness (LOR). At LOR the calculated effect site concentration will be used as reference to mantain anesthesia level. EEG (CONOX or BIS) will be used to evaluate the prediction of the model.

Drug: 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

Interventions

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.

Group 1: the prediction of the Eleveld propofol model in effect site mode TCI induction; Group 2: the prediction of the Eleveld propofol model in TCI plasma mode

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients ASA1-2, 18-70 years, scheduled for elective surgery longer than 1 hour

Sponsors & Collaborators

• Pablo O. Sepulveda: lead

Study Sites (1)

Hospital Base san José de Osorno

Osorno, Los Lagos Region, 5290000, Chile

Location

Related Publications (1)

• Coetzee E, Coetzee JF, Haasbroek M. Predictive pharmacodynamic performance of the Eleveld pharmacokinetic-pharmacodynamic model for propofol: comparison of predicted and measured bispectral index. Br J Anaesth. 2024 Oct;133(4):785-792. doi: 10.1016/j.bja.2024.06.041. Epub 2024 Aug 23.

  PMID: 39179443 RESULT

Related Links

• this study discuss about the problem of the Eleveld effect site prediction using diferent induction flows

MeSH Terms

Interventions

Neoadjuvant Therapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• José Gonzalez Gonzalez, PHD

  Departamento de Investigación Hospital osorno

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Med.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: January 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: from 3 November 2025 to March 2026
• Access Criteria: EEG data and concentration data calculated for each patient will be shared in individual folders via Google Drive.

Locations

CL (1)