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NCT Number: NCT07181564

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

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.

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Key information

Conditions

Magnesium Sulfate Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ketamine Nervous System Diseases Neuron-Specific Enolase Propofol/Remifentanil Remifentanil S 100beta S100 Beta Protein, Human Sevoflurane Anaesthesia Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University General Hospital of Patras

Pátrai, Achaia, 26504, Greece

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

+306949454352

About this study

Functional endoscopic sinus surgery (FESS) is commonly performed under controlled hypotension in order to minimize intraoperative bleeding and optimize the surgical field. However, controlled hypotension may pose a risk of cerebral hypoperfusion and neuronal injury. This prospective, single-center randomized controlled study aims to compare four anesthetic maintenance regimens: (1) propofol-remifentanil, (2) propofol-remifentanil plus continuous ketamine and magnesium infusion, (3) sevoflurane-remifentanil, and (4) sevoflurane-remifentanil plus continuous ketamine and magnesium infusion.

The primary objectives are to evaluate differences in serum S100B and NSE levels at three perioperative time points (baseline before incision, 20 minutes after initiation of controlled hypotension, and at the end of surgery), as well as surgical field quality (7-point Likert scale) and intraoperative bleeding (0-5 scale) as rated by blinded surgeons. Secondary objectives include assessment of extubation conditions with the Aldrete score and evaluation of postoperative pain using a visual analogue scale (VAS). The findings of this trial may help determine whether adjunct agents with potential neuroprotective properties, such as ketamine and magnesium, provide additional benefit during FESS under controlled hypotension.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol / Remifentanil

Drug

Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.

Ketamine + Magnesium sulfate (drug combination)

Drug

Continuous intraoperative infusion per protocol.

sevoflurane and remifentanil

Drug

Continuous intraoperative infusion per protocol.

Primary outcomes

  1. Measure: Serum S100B concentration

    Time frame: 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

    S100B measured in blood samples using institutional clinical laboratory immunoassay methods; values reported in standard laboratory units (e.g., ng/mL).

  2. Measure: Serum neuron-specific enolase (NSE) concentration

    Time frame: 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

    NSE measured in blood samples using institutional clinical laboratory immunoassay methods; values reported in standard laboratory units (e.g., ng/mL).

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

    Time frame: At the end of surgery

    The blinded surgeon will rate surgical field conditions (visibility and bleeding) on a standardized 7-point Likert scale (1 = severe bleeding, 7 = optimal conditions).

  4. Measure: Intraoperative bleeding score (0-5 scale)

    Time frame: At the end of surgery

    Bleeding during surgery assessed on a 0-5 scale, where higher scores indicate heavier bleeding.

Secondary outcomes

  1. Measure: Extubation conditions (Aldrete score, SAS score)

    Time frame: Immediately after extubation in the operating room / upon PACU arrival

    Recovery profile assessed with the Aldrete score (0-10), evaluating activity, respiration, circulation, consciousness, and SpO₂.

  2. Postoperative pain (VAS 0-10)

    Time frame: Within the first 24 hours postoperatively

    Pain intensity measured using the visual analogue scale (VAS, 0-10). Administration of pethidine (0.5-1 mg/kg IM or IV) will be recorded if analgesia was required.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+306949454352

Sponsors and collaborators

Lead sponsor

University General Hospital of Patras

Other

Registry information

Official study title

FUNCTIONAL ENDOSCOPIC NASAL AND SINUS SURGERY AND ANESTHESIA: Study of Hemodynamic Parameters During General Anesthesia Compared to the Surgical Field, as Well as Assessment of Cerebral Ischemia Intraoperatively by Measurement of S100B Protein and Specific Neuronal Enolase (NSE).

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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