Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID07181564

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Follow-up

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

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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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