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

NCT07237477 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Pablo O. Sepulveda

    lead OTHER

Principal Investigators

  • José Gonzalez Gonzalez, PHD · Departamento de Investigación Hospital osorno

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2025-09-15
Completion
2025-09-15
FDA Drug
Yes

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237477 on ClinicalTrials.gov