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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Arterial partial pressure of carbon dioxide (PaCO₂)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Low-flow sevoflurane arm
After tracheal intubation, fresh gas flow will be set at 1 L/min until MAC 1 is achieved. Thereafter, flow will be reduced to 0.5 L/min for maintenance.
干预措施: Common Anesthetic Management (Other)
Minimal-flow sevoflurane anesthesia
Fresh gas flow 1 L/min after intubation until MAC 1 is achieved, then reduced to 0.5 L/min for maintenance anesthesia.
干预措施: Common Anesthetic Management (Other)
结局指标
主要结局
Arterial partial pressure of carbon dioxide (PaCO₂)
时间窗: intraoperative period, from post-intubation to before extubation on the day of surgery
Comparison of arterial PaCO₂ values between the minimal-flow anesthesia group (0.5 L/min) and the low-flow anesthesia group (1 L/min) measured during robot-assisted laparoscopic radical prostatectomy. Arterial blood gas analysis will be performed at predefined intraoperative time points (T0: post-intubation, T1: before pneumoperitoneum, T2: after pneumoperitoneum and positioning, hourly during pneumoperitoneum, at the end of pneumoperitoneum, and before extubation).
次要结局
- End-tidal carbon dioxide (EtCO₂)(intraoperatively)
- Oxygenation parameters(Intraoperative period (T0-Text).)
- Inhalational anesthetic consumption(Postextubation)
研究者
Betül Güven
Assos. Prof
Ankara City Hospital Bilkent