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

NCT07181564 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-09-18

No results posted yet for this study

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.

Conditions

  • Magnesium Sulfate
  • Remifentanil
  • S 100beta
  • S100 Beta Protein, Human
  • Neuron-Specific Enolase
  • Brain Ischemia
  • Sevoflurane Anaesthesia
  • Propofol/Remifentanil
  • Ketamine

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.

Sponsors & Collaborators

  • University General Hospital of Patras

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07181564 on ClinicalTrials.gov