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

NCT07181564 | Recruiting

• 2 other identifiers: 155D0BCB1A1EDDBEE681727C3DAA490000014333
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Magnesium Sulfate; Remifentanil; S 100beta; S100 Beta Protein, Human; Neuron-Specific Enolase; Brain Ischemia; Sevoflurane Anaesthesia; Propofol/Remifentanil; Ketamine

Keywords

"Anesthesia", "Controlled Hypotension", "FESS", "S100B", "Neuron-Specific Enolase"

Outcome Measures

Primary Outcomes (4)

• Measure: Serum S100B concentration

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

  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

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

  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)

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

  At the end of surgery

• Measure: Intraoperative bleeding score (0-5 scale)

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

  At the end of surgery

Secondary Outcomes (2)

• Measure: Extubation conditions (Aldrete score, SAS score)

  Immediately after extubation in the operating room / upon PACU arrival

• Postoperative pain (VAS 0-10)

  Within the first 24 hours postoperatively

Study Arms (4)

Arm 1: Propofol-Remifentanil (TIVA)

ACTIVE COMPARATOR

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

Drug: Propofol / Remifentanil

Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)

ACTIVE COMPARATOR

Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.

Drug: Propofol / Remifentanil; Drug: Ketamine + Magnesium sulfate (drug combination)

Arm 3: Sevoflurane-Remifentanil (Inhalational)

ACTIVE COMPARATOR

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

Drug: Sevoflurane and Remifentanil

Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)

ACTIVE COMPARATOR

Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.

Drug: Ketamine + Magnesium sulfate (drug combination); Drug: Sevoflurane and Remifentanil

Interventions

Propofol / Remifentanil DRUG

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

Arm 1: Propofol-Remifentanil (TIVA); Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)

Ketamine + Magnesium sulfate (drug combination) DRUG

Continuous intraoperative infusion per protocol.

Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+); Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)

Sevoflurane and Remifentanil DRUG

Continuous intraoperative infusion per protocol.

Arm 3: Sevoflurane-Remifentanil (Inhalational); Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.
• Able to provide informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University General Hospital of Patras: lead

Study Sites (1)

University General Hospital of Patras

Pátrai, Achaia, 26504, Greece

RECRUITING

MeSH Terms

Conditions

Brain Ischemia

Interventions

Propofol; Remifentanil; Ketamine; Magnesium Sulfate; Drug Combinations; Sevoflurane

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Pharmaceutical Preparations; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Central Study Contacts

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

CONTACT

+306949454352; rizsotiria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The surgeon who rates the surgical field and the investigator responsible for data analysis are blinded to group allocation. The anesthesiologist is aware of the intervention for safety and drug-delivery reasons.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Resident Anesthesioogy

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: September 11, 2025
• Primary Completion: February 2, 2026
• Study Completion: March 20, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)