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| ID | Type | Description | Link |
|---|---|---|---|
| 0000014333 | Other Identifier | university of patras |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Propofol-Remifentanil (TIVA) | Active Comparator | Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered. |
|
| Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+) | Active Comparator | Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium. |
|
| Arm 3: Sevoflurane-Remifentanil (Inhalational) | Active Comparator | Maintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered. |
|
| Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+) | Active Comparator | Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol / Remifentanil | Drug | Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| 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). | 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 |
| 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). | At the end of surgery |
| Measure: Intraoperative bleeding score (0-5 scale) | Bleeding during surgery assessed on a 0-5 scale, where higher scores indicate heavier bleeding. | At the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Measure: Extubation conditions (Aldrete score, SAS score) | Recovery profile assessed with the Aldrete score (0-10), evaluating activity, respiration, circulation, consciousness, and SpOâ‚‚. | Immediately after extubation in the operating room / upon PACU arrival |
| Postoperative pain (VAS 0-10) |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sotiria Rizopoulou, M.D.,M.Sc. | Contact | +306949454352 | rizsotiria@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University General Hospital of Patras | Recruiting | Pátrai | Achaia | 26504 | Greece |
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The surgeon who rates the surgical field and the investigator responsible for data analysis are blinded to group allocation. The anesthesiologist is aware of the intervention for safety and drug-delivery reasons.
| Ketamine + Magnesium sulfate (drug combination) | Drug | Continuous intraoperative infusion per protocol. |
|
| Sevoflurane and Remifentanil | Drug | Continuous intraoperative infusion per protocol. |
|
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. |
| Within the first 24 hours postoperatively |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D000077208 | Remifentanil |
| D007649 | Ketamine |
| D008278 | Magnesium Sulfate |
| D004338 | Drug Combinations |
| D000077149 | Sevoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D004364 | Pharmaceutical Preparations |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
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