The Effect of Preoperative Patient Warming in the Prevention of Perioperative Hypothermia in Major Abdominal Surgery Under Combined General/Epidural Anaesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Incidence of hypothermic patients at arrival at PACU
研究概览
简要总结
The study should evaluate how long patients undergoing major abdominal surgery under combined general/epidural anaesthesia have to be actively warmed preoperatively to prevent perioperative hypothermia and postoperative shivering. 99 patients will receive forced-air skin-surface warming for different duration. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.
详细描述
The aim of our study is to evaluate the performance of different durations of active preoperative skin-surface warming (prewarming) to prevent perioperative hypothermia in patients undergoing major abdominal surgery under combined general/epidural anaesthesia. The investigators plan to enroll 99 patients in 3 groups. Body temperature will be measured at the tympanic membrane. The investigators hypothesize that active warming before starting the epidural anaesthesia will decrease the incidence of perioperative hypothermia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •age over 18 years
- •planned duration of surgery > 2 hours
- •planned for elective major abdominal surgery under combined epidural/general anaesthesia
- •written informed consent
- •American society of anesthesiologists status 1-3
排除标准
- •duration of surgery < 90 min
- •withdrawal of consent
- •emergency surgery
研究组 & 干预措施
Group 1, control group
No active warming before start of epidural or general anaesthesia, active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C).
Group 2, Prewarming only before general anaesthesia
Active forced-air warming for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C).
干预措施: Forced-air warming (Device)
Group 3, Prewarming before epidural and general anaesthesia
Active forced-air warming for 15 min before start of epidural anaesthesia and for 15 min after completion of epidural anaesthesia / before start of general anaesthesia. Continued active forced-air warming after induction of general anaesthesia until operation is finished (intraoperatively). Application of warmed infusions (41 °C).
干预措施: Forced-air warming (Device)
结局指标
主要结局
Incidence of hypothermic patients at arrival at PACU
时间窗: 2 hours
After the operation patients will be admitted to the PACU. Here, body temperature will be assessed and the incidence of hypothermic patients (body temperature \< 36°C)will be measured.
次要结局
未报告次要终点
研究者
PD Dr. Jan Hoecker
Associate Professor of Anaesthesiology
University Hospital Schleswig-Holstein