Comparison of the Site Effect Model Prediction and BIS Predicted by Eleveld for Propofol in Slow and Rapid Inductions
| Registry | NCT07237477, acronym fast or slow E |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 70 (Actual) |
| Sponsor | Pablo O. Sepulveda (Other) |
| Conditions | Anesthesia for Elective Surgery Patients, Anesthesia Brain Monitor, Pharmacodynamics |
| 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) |
| Dates | start 2025-01-15, primary completion 2025-09-15, completion 2025-09-15, first posted 2025-11-19, last updated 2025-11-19 |
| Locations | 1 site in Chile |
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All trials for Anesthesia for Elective Surgery Patients All trials for Anesthesia Brain Monitor All trials of 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
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group 1: the prediction of the Eleveld propofol model in effect site mode TCI induction | 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 | 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. | |
| Group 2: the prediction of the Eleveld propofol model in TCI plasma mode | 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 | 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. |
Sex: All, ages: 18 Years to 70 Years
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 \-
| Facility | City | Country | Status |
|---|---|---|---|
| Hospital Base san José de Osorno | Osorno, Los Lagos Region | Chile |