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Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison Through qNOX and ANIi Reactions to Post-tetanic Count
Led by University of Padova · Updated on 2026-06-08
100
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating two different pharmacokinetic/pharmacodynamic models used for target-controlled infusion (TCI) of remifentanil, a commonly used opioid during general anesthesia. The study compares the newer Eleveld model with the widely used Minto model to see if there are differences in the remifentanil effect-site concentrations needed to achieve similar analgesia levels. The assessment focuses on measurements from qNOX and the Analgesia Nociception Index (ANI), which monitor the balance of pain signals and analgesic effects during surgery. Additionally, responses to a controlled noxious stimulus called Post-Tetanic Count (PTC) are analyzed during anesthesia maintenance to explore differences in analgesic responses between the two models. Participants receive general anesthesia with propofol guided by the Eleveld TCI model, combined with remifentanil administered either by the Eleveld or Minto TCI model, as decided by the anesthesiologist. The study observes and compares these two groups during the surgical procedure, focusing on the remifentanil concentrations and nociception monitor values. The Post-Tetanic Count stimulation is applied during anesthesia to test how each model modulates analgesia under a standardized painful input. During the study, researchers continuously monitor remifentanil effect-site concentration, qNOX, and ANI values throughout the surgery. They also assess the participants for postoperative delirium and pain shortly after anesthesia ends, as well as evaluate chronic pain six months following surgery. These measurements help determine if the newer Eleveld model offers advantages over the traditional Minto model in guiding remifentanil dosing and analgesia management. The total participant age range is 18 to 80 years, and the study is observational, tracking outcomes without assigning treatments for research purposes.
CONDITIONS
Brief Title
Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Remifentanil (Minto or Eleveld model)
You will not qualify if you...
- Neurological disease
- Psychiatric disease
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of anesthesia and surgery
Participants undergo general anesthesia with Target Controlled Infusion of Propofol using the Eleveld model and Remifentanil using either the Minto or Eleveld model. During anesthesia maintenance, nociception indices (qNOX and ANI) are continuously monitored, including reactions to controlled noxious stimuli (Post-tetanic count).
1 periprocedural visit (in-person during surgery)
Duration - Up to 6 months after surgery
Participants are assessed for postoperative delirium and pain approximately 45 minutes after anesthesia ends in the Post Anesthesia Care Unit, and pain is further evaluated 6 months after surgery to assess chronic pain incidence.
2 visits (1 early post-operative visit and 1 follow-up visit at 6 months)
Trial Site Locations
Total: 1 location
1
ULSS2 Marca Trevigiana
Treviso, Italy, 31100
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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