Adding dexmedetomidine to propofol–remifentanil TIVA to see effects on brain and pain monitors
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
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | University of Padova Academic / other |
| Locations | 1 site (Treviso, TV) |
| Trial ID | NCT07259460 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Treviso, TV
- Treviso Regional Hospital — Treviso, Tv, Italy (Recruiting)
Study contacts
- Study coordinator: Federico Linassi, MD, PhD
- Email: federico.linassi@gmail.com
- Phone: 0422322440
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.