Evaluation of Adding 4% of Oxygen and 10% of Nitrous Oxide to the CO2 Pneumoperitoneum Upon CO2 Resorption.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- CO2 absorption
研究概览
简要总结
CO2 absorption from the pneumoperitoneum increases over time during laparoscopic procedures. Adding 4% of oxygen to the carbon dioxide was shown in rabbits to decrease CO2 resorbtion through prevention of mesothelial hypoxia. We want to prove this concept in human and expand it to the use of full conditioning.
详细描述
In order to confirm the animal data in the human, a first RCT was performed in which 20 women undergoing a laparoscopy for at least 60 minutes were randomised to a pneumoperitoneum with either 100% carbon dioxide or 96% carbon dioxide plus 4% of oxygen. Insufflation pressure and Trendelenburg were standardised at 15 mm Hg and 30° respectively. In a second trial women were randomized to either 100% carbon dioxide or 86% carbon dioxide plus 4% of oxygen + 10% nitrous oxide + humidification and set temperature of 32°C of the peritoneal cavity.
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
- Single (Participant)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women/men planned to undergo a laparoscopic intervention for at least 1 hour and having signed the informed consent
排除标准
- •Pregnancy
- •Immunodeficiency
- •Refuse or unable to sign informed consent
- •Chronic disease (i.e. COPD, Crohn, cardiac...)
结局指标
主要结局
CO2 absorption
时间窗: measurements for 60 to 240 minutes on average during surgery
Measurement of end tidal CO2 during laparoscopic surgery; a decrease would improve safety (less hypercarbia)
次要结局
- hemodynamic alterations(measurements for 60 to 240 minutes on average during surgery)
研究者
Jasper Verguts
MD
University Hospital, Gasthuisberg