Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorUniversity of Padova
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld model) and Remifentanil (Minto or Eleveld model)
Disqualifiers
Neurological disease
Psychiatric disease
Trial population
Women undergoing brast cancer surgery with general anesthesia with Propofol and Remifentanil TCI, will be recruited
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Eleveld TCI
Group B: Minto TCI
Trial outcomes
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)
Time frame
We will consider CeR, qNOX and ANI values during the periprocedural phaseSecondary outcomes
1
Comparison between qNOX and ANI reaction to noxious stimulation delivered by Post-tetanic count during maintenance of anesthesia
Discover if there is indices increase (for qNOX) or decrease (for ANIi) after post-tetanic count stimulation during general anesthesia between the Minto and Eleveld TCI model for Remifentanil
Time frame
qNOX, ANIi will be recorded during the periprocedural phase2
Comparing the incidence of Postoperative Delirium (POD) at anesthesia emergence
Discover if there are different POD rates detected by Confusion Assessment Method (CAM) between Eleveld or Minto TCI models. Higher POD probability with higher CAM scores
Time frame
CAM will be performed in Post Anesthesia Care Unit, 45 minutes after the end of surgery3
Comparing the incidence of pain at anesthesia emergence
Discover if there are different Severe pain rates detected by Numeric Rating Scale (NRS) between Eleveld or Minto TCI models.Higher pain with higher NRS scores
Time frame
NRS will be performed in Post Anesthesia Care Unit, 45 minutes after the end of surgery.4
Comparing the incidence of cronic pain after 6 months from surgery
Discover if there are different Severe pain rates detected by Numeric Rating Scale (NRS) between Eleveld or Minto TCI models.Higher pain with higher NRS scores
Time frame
NRS will be performed after 6 months from surgerySponsors and contacts
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Source ClinicalTrials.gov