Anesthesia methods, neuroprotection, and surgical field in FESS with controlled hypotension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center randomized trial enrolls adult patients undergoing elective functional endoscopic sinus surgery (FESS) under controlled hypotension and randomizes them to one of four anesthesia maintenance regimens: propofol-remifentanil, propofol-remifentanil plus continuous ketamine and magnesium, sevoflurane-remifentanil, or sevoflurane-remifentanil plus continuous ketamine and magnesium. Primary outcomes are serum biomarkers of neuronal injury (S100B and neuron-specific enolase) measured at baseline, 20 minutes after initiation of controlled hypotension, and at the end of surgery, alongside blinded surgeon ratings of surgical field visibility and intraoperative bleeding. Secondary outcomes include extubation conditions measured by the Aldrete score, postoperative pain by visual analogue scale, and recovery profile. The trial examines whether adjunct ketamine and magnesium provide added neuroprotection during periods of controlled hypotension while maintaining hemodynamic stability and acceptable surgical conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria :

Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.

Able to provide informed consent

Exclusion Criteria:

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.

Where it's running

• University General Hospital of Patras
  Pátrai, Achaia, Greece Recruiting

Study contacts

• Study coordinator: Sotiria Rizopoulou, M.D.,M.Sc.
• Email: rizsotiria@gmail.com
• Phone: +306949454352

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.