Pressure Support Ventilation During Laparoscopic and Abdominal Robotic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Concentrations of biomarkers of lung injury
研究概览
简要总结
This study is a single-center, blind, prospective, randomized, controlled trial of pressure support ventilation (PSVpro) versus pressure control ventilation - volume guaranteed (PCV - VG) during laparoscopic and robotic abdominal surgery.
详细描述
The objective of the study to evaluate the possibility and feasibility of using PSVpro during anesthesia during long-term laparoscopic and robot-assisted abdominal operations at different levels of neuromuscular block.
Intervention: We plan to include 100 patients who will undergo elective long (more 2 hours) laparoscopic or abdominal robotic surgery. All patients will be randomly assigned in two groups in ratio 1:1. 1 group- deep neuromuscular block and mandatory ventilation; 2 group- partial neuromuscular block and pressure support ventilation.
Expected Results. PSV may reduce the systemic inflammatory response compared to the mandatory ventilation during laparoscopic and abdominal robotic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written consent.
- •Men and women aged 18 years or more.
- •The physical status from ASA classification I, II or III.
- •BMI <= 34.9 kg / m
- •Low risk of respiratory complications.
- •Laparoscopic surgery in the pelvis.
排除标准
- •The physical status from ASA IV or V.
- •BMI> = 35 kg / m
- •Neuromuscular disease.
- •Allergy to Anesthetic Agents.
- •Operations on two cavities.
- •Operations on the chest cavity.
研究组 & 干预措施
Mandatory ventilation
deep neuromuscular block and mandatory ventilation (PCV-VG);
干预措施: Mandatory ventilation (Procedure)
Pressure support ventilation
partial neuromuscular block and pressure support ventilation (PSVpro).
干预措施: pressure support ventilation (Procedure)
结局指标
主要结局
Concentrations of biomarkers of lung injury
时间窗: 1-3 hours after surgery
Measure concentration of Interleukin-6 (IL-6), Interleukin-8 (IL-8), tumor necrosis factor receptor I / II (sTNF rI / II)) in blood serum
次要结局
- The maximum level of vasopressor support during surgery(From time of skin incision to time of skin closure assessed up to 24 hours)
- Maximum intraoperative lactate level in the early postoperative period(1 hour after surgery)
研究者
Valerii Subbotin
PhD
Moscow Clinical Scientific Center