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

ConditionsMagnesium SulfateRemifentanilS 100betaS100 Beta Protein, HumanNeuron-Specific EnolaseBrain IschemiaSevoflurane AnaesthesiaPropofol/RemifentanilKetamine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity General Hospital of Patras

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Propofol / Remifentanil

    Drug

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

  • Ketamine + Magnesium sulfate (drug combination)

    Drug

    Continuous intraoperative infusion per protocol.

  • Sevoflurane and Remifentanil

    Drug

    Continuous intraoperative infusion per protocol.

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: Arm 1: Propofol-Remifentanil (TIVA)Active comparator 1 intervention
Group B: Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)Active comparator 2 interventions
Group C: Arm 3: Sevoflurane-Remifentanil (Inhalational)Active comparator 1 intervention
Group D: Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Measure: Serum S100B concentration

S100B measured in blood samples using institutional clinical laboratory immunoassay methods; values reported in standard laboratory units (e.g., ng/mL).

Time frame
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
2

Measure: Serum neuron-specific enolase (NSE) concentration

NSE measured in blood samples using institutional clinical laboratory immunoassay methods; values reported in standard laboratory units (e.g., ng/mL).

Time frame
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
3

Measure: Surgical field quality score (7-point Likert scale)

The blinded surgeon will rate surgical field conditions (visibility and bleeding) on a standardized 7-point Likert scale (1 = severe bleeding, 7 = optimal conditions).

Time frame
At the end of surgery
4

Measure: Intraoperative bleeding score (0-5 scale)

Bleeding during surgery assessed on a 0-5 scale, where higher scores indicate heavier bleeding.

Time frame
At the end of surgery

Secondary outcomes

1

Measure: Extubation conditions (Aldrete score, SAS score)

Recovery profile assessed with the Aldrete score (0-10), evaluating activity, respiration, circulation, consciousness, and SpO₂.

Time frame
Immediately after extubation in the operating room / upon PACU arrival
2

Postoperative pain (VAS 0-10)

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.

Time frame
Within the first 24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University General Hospital of Patras

Lead sponsor

Source ClinicalTrials.gov
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