drugset / Trial / NCT07181564

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

NCT07181564

Recruiting 150 enrolled University General Hospital of Patras
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-09-11
Primary completion
2026-02-02
Completion
2026-03-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ketamine Small molecule
Comparator Magnesium Sulfate Other / unclassified
Comparator Propofol Small molecule Intravenous
Comparator Sevoflurane Other / unclassified Inhaled
Comparator Remifentanil Small molecule Intravenous
Comparator Remifentanil Small molecule

Indications