Magnesium SulfateNCT07181564
Anesthesia Techniques, Neuroprotection and Surgical Field in FESS Under Controlled Hypotension
A study testing Propofol / Remifentanil, Ketamine + Magnesium sulfate (drug combination) and Sevoflurane and Remifentanil in people with Magnesium Sulfate and Remifentanil, run by University General Hospital of Patras at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Magnesium Sulfate, Remifentanil, S 100beta
- What is being tested?
- Propofol / Remifentanil, Ketamine + Magnesium sulfate (drug combination) and Sevoflurane and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- 11 Sep 2025to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.
- Able to provide informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University General Hospital of Patras
Pátrai, Achaia, 26504
Sotiria Rizopoulou, M.D.,M.Sc., +306949454352, rizsotiria@gmail.com
About this study
Official title: FUNCTIONAL ENDOSCOPIC NASAL AND SINUS SURGERY AND ANESTHESIA: Study of Hemodynamic Parameters During General Anesthesia Compared to the Surgical Field, as Well as Assessment of Cerebral Ischemia Intraoperatively by Measurement of S100B Protein and Specific Neuronal Enolase (NSE).
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.
Read the detailed 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.
- Conditions
- Magnesium Sulfate, Remifentanil, S 100beta, S100 Beta Protein, Human, Neuron-Specific Enolase, Brain Ischemia
- Being tested
- Propofol / Remifentanil, Ketamine + Magnesium sulfate (drug combination), Sevoflurane and Remifentanil
- Keywords
- "Anesthesia", "Controlled Hypotension", "FESS", "S100B", "Neuron-Specific Enolase"
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol / RemifentanilDrug
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 RemifentanilDrug
Continuous intraoperative infusion per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Propofol-Remifentanil (TIVA) | Active comparator | Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered. Receives: Drug: Propofol / Remifentanil |
| Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+) | Active comparator | Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium. Receives: Drug: Propofol / Remifentanil; Drug: Ketamine + Magnesium sulfate (drug combination) |
| Arm 3: Sevoflurane-Remifentanil (Inhalational) | Active comparator | Maintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered. Receives: Drug: Sevoflurane and Remifentanil |
| Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+) | Active comparator | Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium. Receives: Drug: Ketamine + Magnesium sulfate (drug combination); Drug: Sevoflurane and Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At the end of surgery
Secondary outcomes (2)
Measure: Extubation conditions (Aldrete score, SAS score)
Recovery profile assessed with the Aldrete score (0-10), evaluating activity, respiration, circulation, consciousness, and SpO₂.
Measured: 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.
Measured: Within the first 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start11 Sep 2025
- Primary completion2 Feb 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnesium SulfateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University General Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sotiria Rizopoulou, University General Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07181564
- Sponsor's protocol ID
- 155D0BCB1A1EDDBEE681727C3DAA49
- Other IDs
- 0000014333
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FUNCTIONAL ENDOSCOPIC NASAL AND SINUS SURGERY AND ANESTHESIA: Study of Hemodynamic Parameters During General Anesthesia Compared to the Surgical Field, as Well as Assessment of Cerebral Ischemia Intraoperatively by Measurement of S100B Protein and Specific Neuronal Enolase (NSE).
- ClinicalTrials.gov ID
- NCT07181564
- Acronym / sponsor ID
- 155D0BCB1A1EDDBEE681727C3DAA49
- Conditions
- Magnesium Sulfate, Remifentanil, S 100beta, S100 Beta Protein, Human, Neuron-Specific Enolase, Brain Ischemia
- Keywords
- "Anesthesia", "Controlled Hypotension", "FESS", "S100B", "Neuron-Specific Enolase"
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University General Hospital of PatrasUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Propofol-Remifentanil (TIVA) | Active comparator | Drug: Propofol / RemifentanilMaintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered. |
| Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+) | Active comparator | Drug: Propofol / Remifentanil, Drug: Ketamine + Magnesium sulfate (drug combination)Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium. |
| Arm 3: Sevoflurane-Remifentanil (Inhalational) | Active comparator | Drug: Sevoflurane and RemifentanilMaintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered. |
| Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+) | Active comparator | Drug: Ketamine + Magnesium sulfate (drug combination), Drug: Sevoflurane and RemifentanilMaintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.
- Able to provide informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propofol / RemifentanilMaintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered. | Drug | Arm 1: Propofol-Remifentanil (TIVA), Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+) |
| Ketamine + Magnesium sulfate (drug combination)Continuous intraoperative infusion per protocol. | Drug | Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+), Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+) |
| Sevoflurane and RemifentanilContinuous intraoperative infusion per protocol. | Drug | Arm 3: Sevoflurane-Remifentanil (Inhalational), Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+) |
Primary outcome
Measure: Serum S100B concentration
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
S100B measured in blood samples using institutional clinical laboratory immunoassay methods; values reported in standard laboratory units (e.g., ng/mL).
Measure: Serum neuron-specific enolase (NSE) concentration
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
NSE measured in blood samples using institutional clinical laboratory immunoassay methods; values reported in standard laboratory units (e.g., ng/mL).
Measure: Surgical field quality score (7-point Likert scale)
Time frame: At the end of surgery
The blinded surgeon will rate surgical field conditions (visibility and bleeding) on a standardized 7-point Likert scale (1 = severe bleeding, 7 = optimal conditions).
Measure: Intraoperative bleeding score (0-5 scale)
Time frame: At the end of surgery
Bleeding during surgery assessed on a 0-5 scale, where higher scores indicate heavier bleeding.
2 secondary outcomes
Measure: Extubation conditions (Aldrete score, SAS score)
Time frame: Immediately after extubation in the operating room / upon PACU arrival
Postoperative pain (VAS 0-10)
Time frame: Within the first 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol / Remifentanil, Ketamine + Magnesium sulfate (drug combination) and Sevoflurane and Remifentanil in people with Magnesium Sulfate and Remifentanil, run by University General Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sotiria Rizopoulou, M.D.,M.Sc. (+306949454352, rizsotiria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Serum S100B concentration (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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.