Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under Controlled Hypotension

University General Hospital of Patras

Status: Enrolling

Conditions: S 100beta; Brain Ischemia; Magnesium Sulfate; Ketamine; Remifentanil; S100 Beta Protein, Human; Neuron-Specific Enolase; Propofol/Remifentanil; Sevoflurane Anaesthesia

Treatments: Drug: Ketamine + Magnesium sulfate (drug combination); Drug: Propofol / Remifentanil; Drug: Sevoflurane and Remifentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT07181564

155D0BCB1A1EDDBEE681727C3DAA49

0000014333 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

150 participants in 4 patient groups

Arm 1: Propofol-Remifentanil (TIVA)

Active Comparator group

Description:

Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.

Treatment:

Drug: Propofol / Remifentanil

Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)

Active Comparator group

Description:

Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.

Treatment:

Drug: Propofol / Remifentanil

Drug: Ketamine + Magnesium sulfate (drug combination)

Arm 3: Sevoflurane-Remifentanil (Inhalational)

Active Comparator group

Description:

Maintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered.

Treatment:

Drug: Sevoflurane and Remifentanil

Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)

Active Comparator group

Description:

Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.

Treatment:

Drug: Sevoflurane and Remifentanil

Drug: Ketamine + Magnesium sulfate (drug combination)