Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under Controlled Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Propofol / Remifentanil, Ketamine + Magnesium sulfate (drug combination), Sevoflurane and Remifentanil.
- Who it may be relevant to
- Registry conditions: Magnesium Sulfate, Remifentanil, S 100beta, S100 Beta Protein, Human. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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).
Overview
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.
Interventions
- Drug Propofol / Remifentanil
Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered. - Drug Ketamine + Magnesium sulfate (drug combination)
Continuous intraoperative infusion per protocol. - Drug Sevoflurane and Remifentanil
Continuous intraoperative infusion per protocol.
Primary outcome measures
- 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]
- 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]
- Measure: Surgical field quality score (7-point Likert scale) [Time frame: At the end of surgery]
- Measure: Intraoperative bleeding score (0-5 scale) [Time frame: At the end of surgery]
Secondary outcome measures (2)
- Measure: Extubation conditions (Aldrete score, SAS score) [Time frame: Immediately after extubation in the operating room / upon PACU arrival]
- Postoperative pain (VAS 0-10) [Time frame: Within the first 24 hours postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Greece · 1 center
- University General Hospital of Patras — Pátrai
Identifiers
NCT: NCT07181564 · 155D0BCB1A1EDDBEE681727C3DAA49 · 0000014333