Actively Recruiting
Functional Endoscopic Nasal and Sinus Surgery and Anesthesia: Study of Hemodynamic Parameters and Cerebral Ischemia Assessment by S100B Protein and Neuron-Specific Enolase During Surgery
Led by University General Hospital of Patras · Updated on 2025-09-18
150
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of four different anesthetic maintenance methods on surgical conditions, blood pressure stability, and brain protection during functional endoscopic sinus surgery (FESS) performed with controlled low blood pressure. The study compares propofol-remifentanil alone, propofol-remifentanil with added ketamine and magnesium, sevoflurane-remifentanil alone, and sevoflurane-remifentanil with added ketamine and magnesium. The main focus is on measuring blood markers of brain injury and assessing the quality of the surgical field and bleeding during surgery. Participants are randomly assigned to one of the four groups receiving general anesthesia with either propofol-remifentanil or sevoflurane-remifentanil, with or without continuous infusions of ketamine and magnesium. The infusions are administered continuously during surgery according to the assigned group. This trial is conducted at a single center and includes a triple-blind design to reduce bias. During the study, participants will have blood samples taken at three key times: before surgery starts, 20 minutes after controlled low blood pressure begins, and at surgery end to measure brain injury markers. Surgeons will rate surgical field visibility and bleeding at the end of surgery. Recovery will be assessed immediately after extubation using standard scores, and postoperative pain will be measured within 24 hours. The total participation involves the surgery and immediate postoperative period, with ongoing monitoring of outcomes related to anesthesia methods and brain protection.
CONDITIONS
Brief Title
Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under Controlled Hypotension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older
- Scheduled for functional endoscopic sinus surgery under general anesthesia
- Able to provide informed consent
You will not qualify if you...
- Emergency surgery
- ASA physical status IV or V
- Severe liver or kidney dysfunction
- Known allergy or contraindication to study drugs
- Pregnant or lactating women
- Unable or unwilling to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of surgery and anesthesia
Participants undergo functional endoscopic sinus surgery (FESS) under general anesthesia with one of four anesthetic regimens. Anesthesia is maintained with propofol-remifentanil or sevoflurane-remifentanil, with or without continuous ketamine and magnesium infusion during surgery under controlled hypotension.
1 surgical and anesthesia visit (in-person)
Duration - Up to 24 hours postoperatively
Participants are assessed immediately after extubation and monitored for postoperative pain within the first 24 hours.
1 post-operative visit (in-person)
Trial Site Locations
Total: 1 location
1
University General Hospital of Patras
Pátrai, Achaia, Greece, 26504
Actively Recruiting
Research Team
S
Sotiria Rizopoulou, M.D.,M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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