Anesthesia methods, neuroprotection, and surgical field in FESS with controlled hypotension
FUNCTIONAL ENDOSCOPIC NASAL AND SINUS SURGERY AND ANESTHESIA: Study of Hemodynamic Parameters During General Anesthesia Compared to the Surgical Field, as Well as Assessment of Cerebral Ischemia Intraoperatively by Measurement of S100B Protein and Specific Neuronal Enolase (NSE).
This trial tests whether four different anesthesia maintenance techniques — propofol-remifentanil, propofol-remifentanil with ketamine and magnesium, sevoflurane-remifentanil, and sevoflurane-remifentanil with ketamine and magnesium — better protect the brain and improve the surgical field in adults having FESS under controlled hypotension.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | University General Hospital of Patras Academic / other |
| Locations | 1 site (Pátrai, Achaia) |
| Trial ID | NCT07181564 on ClinicalTrials.gov |
What this trial studies
This prospective, single-center randomized trial enrolls adult patients undergoing elective functional endoscopic sinus surgery (FESS) under controlled hypotension and randomizes them to one of four anesthesia maintenance regimens: propofol-remifentanil, propofol-remifentanil plus continuous ketamine and magnesium, sevoflurane-remifentanil, or sevoflurane-remifentanil plus continuous ketamine and magnesium. Primary outcomes are serum biomarkers of neuronal injury (S100B and neuron-specific enolase) measured at baseline, 20 minutes after initiation of controlled hypotension, and at the end of surgery, alongside blinded surgeon ratings of surgical field visibility and intraoperative bleeding. Secondary outcomes include extubation conditions measured by the Aldrete score, postoperative pain by visual analogue scale, and recovery profile. The trial examines whether adjunct ketamine and magnesium provide added neuroprotection during periods of controlled hypotension while maintaining hemodynamic stability and acceptable surgical conditions.
Who should consider this trial
Good fit: Adults (≥18) scheduled for elective FESS under general anesthesia who can give informed consent and do not have severe hepatic or renal dysfunction, pregnancy, or contraindications to the study drugs are ideal candidates.
Not a fit: Patients having emergency surgery, with ASA IV–V, severe hepatic or renal failure, pregnancy or lactation, known allergy to study drugs, or inability to consent would not be eligible and thus would not receive benefit from participation.
Why it matters
Potential benefit: If successful, adding ketamine and magnesium could lower markers of neuronal injury, reduce bleeding and improve surgical visibility and recovery for patients having FESS under hypotension.
How similar studies have performed: Some prior studies suggest ketamine and magnesium may have neuroprotective or anesthetic-sparing effects in other surgical contexts, but evidence in FESS under controlled hypotension is limited and mixed, making this application relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia. Able to provide informed consent Exclusion Criteria: Emergency surgery. ASA physical status IV-V. Severe hepatic or renal dysfunction. Known allergy or contraindication to study drugs. Pregnant or lactating women. unable to provide informed consent Patients unwilling or unable to provide consent.
Where this trial is running
Pátrai, Achaia
- University General Hospital of Patras — Pátrai, Achaia, Greece (Recruiting)
Study contacts
- Study coordinator: Sotiria Rizopoulou, M.D.,M.Sc.
- Email: rizsotiria@gmail.com
- Phone: +306949454352
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.