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

NCT07259291 | Recruiting DMC

• 1 other identifier: RemiMAST
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Propofol; Anesthesia Brain Monitoring; Remifentanil

Keywords

Analgesia monitoring

Outcome Measures

Primary Outcomes (1)

• Comparison between Concentration at the effector site of Remifentanil (CeR) during anesthesia maintenance

  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)

  We will consider CeR, qNOX and ANI values during the periprocedural phase

Secondary Outcomes (4)

• Comparison between qNOX and ANI reaction to noxious stimulation delivered by Post-tetanic count during maintenance of anesthesia

  qNOX, ANIi will be recorded during the periprocedural phase

• Comparing the incidence of Postoperative Delirium (POD) at anesthesia emergence

  CAM will be performed in Post Anesthesia Care Unit, 45 minutes after the end of surgery

• Comparing the incidence of pain at anesthesia emergence

  NRS will be performed in Post Anesthesia Care Unit, 45 minutes after the end of surgery.

• Comparing the incidence of cronic pain after 6 months from surgery

  NRS will be performed after 6 months from surgery

Study Arms (2)

Eleveld TCI

Patients who received general anesthesia with Eleveld TCI model for Propofol and Remifentanil (this model was choosen at anesthesiologist's discretion)

Minto TCI

Patients who received general anesthesia with Eleveld TCI model for Propofol and Minto TCI for Remifentanil (this model was choosen at anesthesiologist's discretion)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, will be recruited

You may qualify if:

• Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Remifentanil (Minto or Eleveld model)

You may not qualify if:

• Neurological disease
• Psychiatric disease

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

ULSS2 Marca Trevigiana

Treviso, 31100, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal investigator

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 2, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

IT (1)