Impact of Prewarming on Perioperative Body Core Temperature and the Outcomes of Cytoreductive- and Major Open Abdominal Surgery: A Randomised Trial (PREWARM)
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- body core temperature drop from induction of anesthesia to start of surgery
研究概览
简要总结
The primary purpose of this study is to determine whether a prewarming period of at least 30 minutes during induction of general and combined epidural anesthesia reduces the core temperature drop normally occuring in patients undergoing cyto-reductive and major abdominal surgery. In addition the effect of prewarming on intra and postoperative body core temperature will be evaluated.
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
- None
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
- •age > 18
- •elective cytoreductive or major abdominal surgery caused by ovarian cancer, primarily or secondary
排除标准
- •age < 18
- •refusal participate in study
- •pregnant or breast-feeding women
- •cardiac ejection fraction < 30%
- •terminal renal insufficiency requiring dialysis
- •severe pulmonary disease (Gina-Classification< 3)
- •neurological and/or psychiatric disease
- •patient is placed in an institution due to court order
- •lack of language skills/understanding
- •employee of Charité Berlin
- •alcohol addiction
- •refusal of epidural anesthesia or failure to insert epidural catheter
- •participation in other perioperative, invasive studies which prohibit further study inclusion
研究组 & 干预措施
Standard
Study arm in which patients are treated according to standard operating procedures. Acting as "control arm".
Standard + Microdialysis
Study arm in which patients are treated according to standard operating procedures but also receive Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue.
干预措施: Microdialysis (Device)
Prewarm
Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
干预措施: Prewarming (Other)
Prewarm + Microdialysis
Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia and Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue
干预措施: Prewarming (Other)
Prewarm + Microdialysis
Study arm in which patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia and Microdialysis through a small catheter which is inserted into subcutaneous upper arm fatty tissue
干预措施: Microdialysis (Device)
结局指标
主要结局
body core temperature drop from induction of anesthesia to start of surgery
时间窗: approximately 30-40 minutes
次要结局
- body core temperature at the end of surgery(duration of surgery)
研究者
Michael Sander
Univ.-Prof. M. Sander
Charite University, Berlin, Germany