Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Postoperative Pain
研究概览
简要总结
The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea.
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 bariatric surgery (LBS)
- •American Society of Anaesthesiologists (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
- •complication, Clavien-Dindo grade ≥ II
研究组 & 干预措施
Pulmonary recruitment maneuver
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
干预措施: Pulmonary recruitment maneuver (Procedure)
Pulmonary recruitment maneuver
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
干预措施: Laparoscopic bariatric surgery (Procedure)
Pulmonary recruitment maneuver
Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
干预措施: Ventilator (Device)
Control group
Ordinary ventilation at the end of laparoscopic bariatric surgery.
干预措施: Ventilator (Device)
Control group
Ordinary ventilation at the end of laparoscopic bariatric surgery.
干预措施: Laparoscopic bariatric surgery (Procedure)
结局指标
主要结局
Postoperative Pain
时间窗: 4, 12, 24, 36 and 48 hours after surgery
A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.
次要结局
- Postoperative Nausea(4, 12, 24, 36 and 48 hours after surgery)
研究者
Ebba Kihlstedt Pasquier
Principal Investigator
Region Östergötland