Comparing Minto and Eleveld remifentanil target-controlled infusion models during general anesthesia
Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison Through qNOX and ANIi Reactions to Post-tetanic Count
This study tests whether the newer Eleveld remifentanil infusion model gives similar effect-site concentrations for pain control as the commonly used Minto model in adults having general anesthesia with propofol.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | University of Padova Academic / other |
| Locations | 1 site (Treviso) |
| Trial ID | NCT07259291 on ClinicalTrials.gov |
What this trial studies
Remifentanil, a short-acting opioid, is commonly delivered by target-controlled infusion (TCI) using pharmacokinetic/pharmacodynamic models to maintain a desired effect-site concentration. This observational study compares the routinely used Minto model with the more recently developed Eleveld model by recording predicted remifentanil effect-site concentrations (CeR) and correlating them with nociception measures including qNOX (CONOX monitor), Analgesia Nociception Index (ANI), and post-tetanic count during maintenance. Participants receive propofol TCI using the Eleveld propofol model and remifentanil via either the Minto or Eleveld remifentanil model while standard monitoring is performed. The goal is to determine whether the two models require different CeR to achieve similar analgesic/nociceptive readouts.
Who should consider this trial
Good fit: Adults scheduled for general anesthesia using target-controlled infusions of propofol (Eleveld model) and remifentanil (Minto or Eleveld) without neurological or psychiatric disease are ideal candidates.
Not a fit: Patients with neurological or psychiatric disorders, children, or anyone not receiving TCI of propofol and remifentanil are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If the Eleveld model better matches nociception signals, it could help clinicians dose remifentanil more accurately and reduce under- or over-dosing during anesthesia.
How similar studies have performed: The Minto model is well established in clinical practice while the Eleveld model is newer and based on large pooled datasets, but direct head-to-head clinical comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Treviso
- ULSS2 Marca Trevigiana — Treviso, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.