A Prospective, Blinded, Randomized Clinical Trial Investigating the Effect on Postoperative Pain and Nausea, When Performing a Ventilator-piloted PRM at the End of Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Change in postoperative pain assessed with a numeric rating scale
研究概览
简要总结
This prospective, blinded, randomized clinical trial investigates the effect on postoperative pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic cholecystectomy.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •elective laparoscopic cholecystectomy
- •American Society of Anesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2)
- •written consent
排除标准
- •conversion to open surgery
- •Clavien-Dindo grade ≥ II
研究组 & 干预措施
Pulmonary recruitment maneuver
One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
干预措施: Pulmonary Recruitment Maneuver (Procedure)
Pulmonary recruitment maneuver
One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
干预措施: Laparoscopic cholecystectomy (Procedure)
Pulmonary recruitment maneuver
One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
干预措施: Ventilator (Device)
Control group
Ordinary ventilation at the end of laparoscopic cholecystectomy.
干预措施: Laparoscopic cholecystectomy (Procedure)
Control group
Ordinary ventilation at the end of laparoscopic cholecystectomy.
干预措施: Ventilator (Device)
结局指标
主要结局
Change in postoperative pain assessed with a numeric rating scale
时间窗: 4, 12, 24, 36 and 48 hours after surgery
A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.
次要结局
- Change in postoperative nausea assessed with a Questionnaire(4, 12, 24, 36 and 48 hours after surgery)
研究者
Ebba Kihlstedt Pasquier
Principal Investigator
Region Östergötland