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RECRUITING
NCT07181564
NA

Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under Controlled Hypotension

Sponsor: University General Hospital of Patras

View on ClinicalTrials.gov

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.

Official title: 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).

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-09-11

Completion Date

2026-03-20

Last Updated

2025-09-18

Healthy Volunteers

No

Interventions

DRUG

Propofol / Remifentanil

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

DRUG

Ketamine + Magnesium sulfate (drug combination)

Continuous intraoperative infusion per protocol.

DRUG

Sevoflurane and Remifentanil

Continuous intraoperative infusion per protocol.

Locations (1)

University General Hospital of Patras

Pátrai, Achaia, Greece