RecruitingNot Applicable

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

Greece150 participantsStarted 2025-09-11

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Measure: Serum S100B concentration

Timeframe: Prior to surgical incision (baseline), 20 minutes after initiation of controlled hypotension, and at the end of functional endoscopic sinus surgery (FESS) under controlled hypotension

Measure: Serum neuron-specific enolase (NSE) concentration

Timeframe: Prior to surgical incision (baseline), 20 minutes after initiation of controlled hypotension, and at the end of functional endoscopic sinus surgery (FESS) under controlled hypotension

Measure: Surgical field quality score (7-point Likert scale)

Timeframe: At the end of surgery

Measure: Intraoperative bleeding score (0-5 scale)

Timeframe: At the end of surgery

Trial details

NCT IDNCT07181564

SponsorUniversity General Hospital of Patras

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-02

Contact for this trial

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

+306949454352 rizsotiria@gmail.com

View on ClinicalTrials.gov More Magnesium Sulfate trials

Plain-language summary

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Measure: Serum S100B concentration

Timeframe: Prior to surgical incision (baseline), 20 minutes after initiation of controlled hypotension, and at the end of functional endoscopic sinus surgery (FESS) under controlled hypotension

Measure: Serum neuron-specific enolase (NSE) concentration

Timeframe: Prior to surgical incision (baseline), 20 minutes after initiation of controlled hypotension, and at the end of functional endoscopic sinus surgery (FESS) under controlled hypotension

Measure: Surgical field quality score (7-point Likert scale)

Timeframe: At the end of surgery

Measure: Intraoperative bleeding score (0-5 scale)

Timeframe: At the end of surgery