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).

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

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

• Able to provide informed consent

Locations
Other Locations
Greece
University General Hospital of Patras
RECRUITING
Pátrai
Contact Information
Primary
Sotiria Rizopoulou, M.D.,M.Sc.
rizsotiria@gmail.com
+306949454352
Time Frame
Start Date: 2025-09-11
Estimated Completion Date: 2026-03-20
Participants
Target number of participants: 150
Treatments
Active_comparator: Arm 1: Propofol-Remifentanil (TIVA)
Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.
Active_comparator: Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)
Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
Active_comparator: Arm 3: Sevoflurane-Remifentanil (Inhalational)
Maintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered.
Active_comparator: Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)
Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
Related Therapeutic Areas
Sponsors
Leads: University General Hospital of Patras

This content was sourced from clinicaltrials.gov