Magnesium Sulfate, Remifentanil, S 100beta, S100 Beta Protein, Human, Neuron-Specific Enolase, Brain Ischemia, Sevoflurane Anaesthesia, Propofol/Remifentanil, Ketamine
Conditions
Keywords
Anesthesia, Controlled Hypotension, FESS, S100B, Neuron-Specific Enolase
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.
Interventions
Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.
Continuous intraoperative infusion per protocol.
Continuous intraoperative infusion per protocol.
Sponsors
University General Hospital of Patras
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Greece
Contacts
Primary ContactSotiria Rizopoulou, M.D.,M.Sc.
Outcome results
None listed