RecruitingNot ApplicableNCT07181564

Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under 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).


Sponsor

University General Hospital of Patras

Enrollment

150 participants

Start Date

Sep 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective, randomized controlled trial investigates the effect of four different anesthetic maintenance techniques on surgical field conditions, hemodynamic stability, and neuroprotection during functional endoscopic sinus surgery (FESS) performed under controlled hypotension. Patients are randomly assigned to receive either total intravenous anesthesia with propofol-remifentanil, propofol-remifentanil with adjunct ketamine and magnesium, sevoflurane-remifentanil, or sevoflurane-remifentanil with adjunct ketamine and magnesium. Primary outcomes include serum biomarkers of neuronal injury (S100B and neuron-specific enolase, NSE) measured perioperatively, as well as surgical field visibility and intraoperative bleeding scores. Secondary outcomes include recovery profile and postoperative pain.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria2

  • Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.
  • Able to provide informed consent

Exclusion Criteria2

  • 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.

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Interventions

DRUGPropofol / Remifentanil

Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.

DRUGKetamine + Magnesium sulfate (drug combination)

Continuous intraoperative infusion per protocol.

DRUGSevoflurane and Remifentanil

Continuous intraoperative infusion per protocol.


Locations(1)

University General Hospital of Patras

Pátrai, Achaia, Greece

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NCT07181564


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