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Идёт набор NCT07181564

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

Без фазы С лечением Magnesium Sulfate Remifentanil S 100beta S100 Beta Protein, Human

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Propofol / Remifentanil, Ketamine + Magnesium sulfate (drug combination), Sevoflurane and Remifentanil.
Кому может быть актуально
Состояния в реестре: Magnesium Sulfate, Remifentanil, S 100beta, S100 Beta Protein, Human. Базовые параметры: 18 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Греция
Следующий шаг
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Официальное название

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).

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Propofol / Remifentanil
    Maintenance of general anesthesia with propofol and remifentanil; no ketamine or magnesium administered.
  • Препарат Ketamine + Magnesium sulfate (drug combination)
    Continuous intraoperative infusion per protocol.
  • Препарат Sevoflurane and Remifentanil
    Continuous intraoperative infusion per protocol.

Первичные конечные точки

  • Measure: Serum S100B concentration [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: At the end of surgery]
  • Measure: Intraoperative bleeding score (0-5 scale) [Срок оценки: At the end of surgery]
Вторичные конечные точки (2)
  • Measure: Extubation conditions (Aldrete score, SAS score) [Срок оценки: Immediately after extubation in the operating room / upon PACU arrival]
  • Postoperative pain (VAS 0-10) [Срок оценки: Within the first 24 hours postoperatively]

Критерии участия

Критерии включения

Adult patients (≥18 years old). Scheduled for F.E.S.S (Functional endoscopic sinus surgery ) under general anesthesia.

Able to provide informed consent

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Лечение

Центры проведения

Греция · 1 центр
  • University General Hospital of Patras — Pátrai

Идентификаторы

NCT: NCT07181564 · 155D0BCB1A1EDDBEE681727C3DAA49 · 0000014333

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗