Low-flow Versus Minimal-flow Sevoflurane Anesthesia During Robot-assisted Laparoscopic Radical Prostatectomy

Официальное название

A Prospective Randomized Study Comparing Low-Flow (1 L/Min) and Minimal-Flow (0.5 L/Min) Sevoflurane Anesthesia in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy

Обзор

Study Synopsis This protocol is formatted for ClinicalTrials.gov-style registration and manuscript-facing documentation. It is based on the uploaded Turkish ethics protocol and keeps the original core design: comparison of low-flow and minimal-flow sevoflurane anesthesia in robot-assisted laparoscopic radical prostatectomy. Background and Rationale Robot-assisted laparoscopic radical prostatectomy (RALRP) is increasingly preferred for localized prostate cancer because of lower blood loss, reduced transfusion requirements, shorter hospitalization, and lower complication rates compared with open surgery. However, RALRP requires carbon dioxide pneumoperitoneum and steep Trendelenburg positioning, both of which may adversely affect respiratory mechanics, gas exchange, and hemodynamic stability. Low-flow and minimal-flow anesthesia may improve humidification and warming of inspired gases, reduce inhalational agent consumption, decrease environmental waste, and potentially lower overall cost. Despite these theoretical and practical advantages, evidence remains limited regarding the physiologic safety and performance of minimal-flow sevoflurane anesthesia during long robotic pelvic surgery performed under pneumoperitoneum and steep Trendelenburg positioning. Accordingly, this randomized prospective trial will compare low-flow (1 L/min) and minimal-flow (0.5 L/min) sevoflurane anesthesia during RALRP with respect to respiratory parameters, arterial blood gas values, intraoperative oxygenation variables, anesthetic consumption, and selected postoperative biochemical markers.

Вмешательства

• Другое Common Anesthetic Management
  Standard intraoperative monitoring including BIS, pulse oximetry, temperature, and anesthesia workstation-derived respiratory variables. * Arterial blood gas sampling after intubation, before pneumoperitoneum, after pneumoperitoneum/positioning, hourly during pneumoperitoneum, at the end of pneumoperitoneum in supine position, and before extubation. * Routine safety limits on the anesthesia machine: end-tidal carbon dioxide upper alarm 45 mmHg, inspired oxygen lower alarm 35%, inspired carbon d

Первичные конечные точки

• Arterial partial pressure of carbon dioxide (PaCO₂) [Срок оценки: intraoperative period, from post-intubation to before extubation on the day of surgery]

Вторичные конечные точки (3)

• End-tidal carbon dioxide (EtCO₂) [Срок оценки: intraoperatively]
• Oxygenation parameters [Срок оценки: Intraoperative period (T0-Text).]
• Inhalational anesthetic consumption [Срок оценки: Postextubation]

Критерии участия

Критерии включения

• Male patients aged 18 years or older.
• ASA physical status I-II.
• Scheduled for elective robot-assisted laparoscopic radical prostatectomy.
• Provision of written informed consent. Exclusion Criteria
• ASA physical status III-V.
• Severe cardiac, respiratory, hepatic, or renal disease.
• Mental status disorder or significant hearing impairment that prevents consent or communication.
• Known anxiety, depression, or other psychiatric disorder judged to interfere with study participation.
• Withdrawal of consent or investigator decision for safety reasons.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07475533 · TABED1-26-2261

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗