Adding dexmedetomidine to propofol–remifentanil TIVA to see effects on brain and pain monitors
Official title: Effects of Dexmedetomidine Delivered With Target Controlled Infusion (TCI) on Patient State Index Values, Electroencephalographic Spectrum, Analgesia Nociception Index nd Pupillomtry Values During Total Intravenous Anesthesia With Propofol TCI
Run by University of Padova · NCT07259460 · Data updated 2026-11-12
This project will try giving a controlled infusion of dexmedetomidine alongside propofol and remifentanil during intravenous anesthesia to see if it changes brain-monitoring and pain-monitoring signals in patients having general anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | University of Padova Academic / other |
| Locations | 1 site (Treviso, TV) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | July 30, 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07259460 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing general anesthesia with propofol and remifentanil target-controlled infusions who do not have neurological or psychiatric disorders, are not obese, and are not receiving regional anesthesia.
✕Probably not a fit
Patients with neurological or psychiatric disease, obesity, or those receiving regional anesthesia are excluded and are unlikely to benefit directly from this protocol or its findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will add dexmedetomidine via a target-controlled infusion (Dyck model) during maintenance of total intravenous anesthesia with propofol and remifentanil administered by TCI (Eleveld model). Investigators will record Patient State Index (PSi), EEG power spectrum, Analgesia Nociception Index (ANI), and pupillometry values to characterize neurophysiological and autonomic changes. Patients with neurological or psychiatric disease, obesity, or those receiving regional anesthesia will be excluded. The goal is to determine whether predictable, clinically relevant changes occur that could support more precise drug titration and enhance intraoperative safety.
Why it matters
Potential benefit: If successful, the findings could help anesthesiologists titrate sedative and analgesic drugs more precisely and improve intraoperative monitoring and patient safety.
How similar studies have gone: Using dexmedetomidine to alter EEG and sedation measures has been reported in other contexts, but applying a Dyck-model TCI of dexmedetomidine during propofol–remifentanil TIVA has not been previously studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Undergo general anaesthesia with Targeted Controlled Infusion of Propofol and Rmifntanil (Eleveld model) and Dexmedetomidine (Dyck model) Exclusion Criteria: * Neurological disease * Psychiatric disease * Obesity * Regional anesthesia performed
Where it's running
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Treviso Regional Hospital
Treviso, Tv, Italy Recruiting
Study contacts
- Study coordinator: Federico Linassi, MD, PhD
- Email: federico.linassi@gmail.com
- Phone: 0422322440
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.