Ireland
--:--IST
Recruiting Observational

Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison

NCT07259291 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-11-25
Last updated
2026-06-08

Condition(s) studied

PropofolAnesthesia Brain MonitoringRemifentanil

Study summary

Remifentanil is commonly used as an opioid during general anesthesia. In recent years, several pharmacokinetic/pharmacodynamic (PK/PD) models for target-controlled infusion (TCI) have been developed, with the Eleveld model being one of the most recent and designed for broad applicability.

The aim of this study is to compare the Eleveld TCI model with the routinely used Minto model, in order to evaluate potential differences in the predicted effect-site concentrations (CeR) required to achieve equivalent analgesia levels, as measured by qNOX (CONOX monitor) and the Analgesia Nociception Index (ANI). Post-Tetanic Count (PTC) was also assessed during the maintenance phase to investigate possible differences in nociceptive index responses between the two TCI models.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Remifentanil (Minto or Eleveld model) Exclusion Criteria: * Neurological disease * Psychiatric disease

Primary outcome measure(s)

  • Comparison between Concentration at the effector site of Remifentanil (CeR) during anesthesia maintenance — We will consider CeR, qNOX and ANI values during the periprocedural phase
    Discover if there are differences between CeR of Eleveld and Minto TCI to aim at the same analgesic depth as measured by qNOX (40-60) and ANI (50-70)

Trial sites (1)

FacilityCityRegionStatus
ULSS2 Marca Trevigiana Treviso Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07259291 on ClinicalTrials.gov ↗ ← All trials in Italy