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

Not Applicable

Recruiting

• Conditions: Magnesium Sulfate; Remifentanil; S 100beta; S100 Beta Protein, Human; Neuron-Specific Enolase; Brain Ischemia; Sevoflurane Anaesthesia; Ketamine; Propofol/Remifentanil
• Interventions: Drug: Propofol / Remifentanil; Drug: Ketamine + Magnesium sulfate (drug combination); Drug: Sevoflurane and Remifentanil

• Registration Number: NCT07181564
• Lead Sponsor: University General Hospital of Patras

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-11
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-18
• Last Update Posted: 2025-09-18
• Primary Completion: 2026-02-02
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Propofol-Remifentanil (TIVA)	Propofol / Remifentanil	Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.
Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)	Sevoflurane and Remifentanil	Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)	Propofol / Remifentanil	Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
Arm 3: Sevoflurane-Remifentanil (Inhalational)	Sevoflurane and Remifentanil	Maintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered.
Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)	Ketamine + Magnesium sulfate (drug combination)	Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)	Ketamine + Magnesium sulfate (drug combination)	Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.

Primary Outcome Measures

Name	Time	Method
Measure: Serum S100B concentration	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).
Measure: Serum neuron-specific enolase (NSE) concentration	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).
Measure: Surgical field quality score (7-point Likert scale)	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).
Measure: Intraoperative bleeding score (0-5 scale)	At the end of surgery	Bleeding during surgery assessed on a 0-5 scale, where higher scores indicate heavier bleeding.

Secondary Outcome Measures

Name	Time	Method
Measure: Extubation conditions (Aldrete score, SAS score)	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.
Postoperative pain (VAS 0-10)	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.

Trial Locations

Locations (1)

University General Hospital of Patras; 🇬🇷 Pátrai, Achaia, Greece