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).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Measure: Serum S100B concentration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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.
研究组 & 干预措施
Arm 1: Propofol-Remifentanil (TIVA)
Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.
干预措施: Propofol / Remifentanil (Drug)
Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)
Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
干预措施: Propofol / Remifentanil (Drug)
Arm 2: Propofol-Remifentanil + Ketamine + Magnesium (TIVA+)
Maintenance with propofol and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
干预措施: Ketamine + Magnesium sulfate (drug combination) (Drug)
Arm 3: Sevoflurane-Remifentanil (Inhalational)
Maintenance of general anesthesia with sevoflurane and remifentanil; no ketamine or magnesium administered.
干预措施: Sevoflurane and Remifentanil (Drug)
Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)
Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
干预措施: Ketamine + Magnesium sulfate (drug combination) (Drug)
Arm 4: Sevoflurane-Remifentanil + Ketamine + Magnesium (Inhalational+)
Maintenance with sevoflurane and remifentanil plus adjunct continuous infusions of ketamine and magnesium.
干预措施: Sevoflurane and Remifentanil (Drug)
结局指标
主要结局
Measure: Serum S100B concentration
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: At the end of surgery
Bleeding during surgery assessed on a 0-5 scale, where higher scores indicate heavier bleeding.
次要结局
- Measure: Extubation conditions (Aldrete score, SAS score)(Immediately after extubation in the operating room / upon PACU arrival)
- Postoperative pain (VAS 0-10)(Within the first 24 hours postoperatively)
研究者
Sotiria Rizopoulou
Chief Resident Anesthesioogy
University General Hospital of Patras