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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Re-evaluation of the Effect Site Model of the PKPD Propofol Eleveld Model

NCT06417645

Healthy Surgery

RECRUITING PHASE4

Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response

NCT01665079

Obesity

COMPLETED PHASE4

Pharmacokinetic/Pharmacodynamic Model of Propofol in Children

NCT02544854

Anesthesia

UNKNOWN PHASE4

Propofol Pharmacokinetics and Pharmacodynamics Modelling

NCT02713698

Intravenous Anesthetic Agent Overdose

COMPLETED

Evaluation of Influencing Variables in Awakening Concentration and Concentration at Body Movements of Propofol TCI (Targeted Controlled Infusion) Targeted at the Effector Site

NCT04129112

Awareness, Anesthesia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Data analysis tool: Stata 10 software
2. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anesthesia for Elective Surgery Patients Anesthesia Brain Monitor Pharmacodynamics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

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

Intervention Type 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 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.

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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.

Intervention Type DRUG