Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
NCT07181564

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

Led by University General Hospital of Patras · Updated on 2025-09-18

150

Participants Needed

1

Research Sites

27 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years old or older
  • Scheduled for functional endoscopic sinus surgery (FESS) under general anesthesia
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Emergency surgery
  • American Society of Anesthesiologists (ASA) physical status IV or V
  • Severe liver or kidney dysfunction
  • Known allergy or contraindication to study drugs (propofol, remifentanil, ketamine, magnesium, sevoflurane)
  • Pregnant or lactating women
  • Unable or unwilling to provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

University General Hospital of Patras

Pátrai, Achaia, Greece, 26504

Actively Recruiting

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Research Team

S

Sotiria Rizopoulou, M.D.,M.Sc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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