Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 6
- 主要终点
- Evolution of core temperature
研究概览
简要总结
During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.
The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:
- CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl
- CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl
- CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%
- CO2 dry and cold with direct intra-abdominal administration of Nacl
The investigators use a new device (Aeroneb® Pro [Aerogen® Company]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Womb surgery by laparoscopy
- •Aged over 18 years
- •No emergency
排除标准
- •Laparotomy
- •Protocol rejected by the patient
- •Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas
结局指标
主要结局
Evolution of core temperature
时间窗: From the beginning of the anesthetic procedure to the discharge of the recovery room.
Post-operative pain
时间窗: From the arrival in the recovery room to the 6th post-operative day.
次要结局
- Inflammation parameters(From the beginning of the anesthetic procedure to the end of the surgical procedure (one blood sample is done before the surgery, the second is done just after the arrival in the recovery room))
- Quality of life(From the discharge of the recovery room to the 6th post-operative day)
- Surgical comfort(During the duration of the surgical procedure.)