An interventional study of Propofol / Remifentanil and Ketamine + Magnesium sulfate (drug combination) in Magnesium Sulfate, Remifentanil and S 100beta, sponsored by University General Hospital of Patras. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by University General Hospital of Patras · Not applicable, Interventional, and Treatment
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.
217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.
This study's planned enrollment of 150 is above the median of 73 across 140 interventional studies indexed under Brain Ischemia.
Browse Brain Ischemia studies →University General Hospital of Patras is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.
Able to provide
Exclusion Criteria:
Emergency surgery. IV-V. Severe hepatic or renal dysfunction. Known allergy or to study drugs. Pregnant or lactating women. unable to provide
Patients unwilling or unable to provide consent.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.
Drug: Propofol / Remifentanil
Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
Drug: Propofol / Remifentanil · Drug: Ketamine + Magnesium sulfate (drug combination)
Maintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered.
Drug: Sevoflurane and Remifentanil
Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
Drug: Ketamine + Magnesium sulfate (drug combination) · Drug: Sevoflurane and Remifentanil
Drug pages: Propofol · Remifentanil
Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.
Drug page: Drug Combinations
Continuous intraoperative infusion per protocol.
Drug pages: Sevoflurane · Remifentanil
Continuous intraoperative infusion per protocol.
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
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Feb 2026, 4 months after the start.
Of 43 interventional studies with no phase under Brain Ischemia, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 4 months is below that.
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Studies of the drugs tested here: Propofol · Remifentanil · Drug Combinations · Sevoflurane
University General Hospital of Patras