Development of an Algorithm Using Clinical Tests to Avoid Post-operative Residual Neuromuscular Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 5
- 主要终点
- Clinical muscle function tests
研究概览
简要总结
Objective neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologist just use qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this study is to develop an algorithm of muscle function tests to identify PORC
详细描述
Background: Quantitative neuromuscular monitoring is the gold standard to detect postoperative residual curarization (PORC). Many anesthesiologists, however, use insensitive, qualitative neuromuscular monitoring or unreliable, clinical tests. Goal of this multicentre, prospective, double-blinded, assessor controlled study is to develop an algorithm of muscle function tests to identify PORC.
Methods: After extubation a blinded anesthetist performs eight clinical tests in 165 patients. Test results are correlated to calibrated electromyography train-of-four (TOF) ratio and to a postoperatively applied uncalibrated acceleromyography. A classification and regression tree (CART) is calculated developing the algorithm to identify PORC. This is validated against uncalibrated acceleromyography and tactile judgement of TOF fading in separate 100 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Immediately after extubation the blinded anaesthesiologist (care provider), who performs anesthesia, tests the patient in the operating room.
The blinded anaesthesiologist is unable to see the data on the EMG monitor and the movement of the adductor pollicis muscle.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients were scheduled for elective low risk surgical procedures:
- •laparoscopic abdominal procedures
- •orthopedic
- •minor visceral surgery
排除标准
- •participation in another study
- •body mass index over 30
- •history of neuromuscular diseases
- •gastro-esophageal reflux disease.
研究组 & 干预措施
Electromyography
Neuromuscular function was monitored, using evoked electromyography of the adductor pollicis muscle with a neuromuscular transmission module by a non-blinded investigator.
Acceleromyography
Immediately after extubation the blinded anaesthesiologist tested with an uncalibrated acceleromyography on the contralateral arm.
干预措施: Acceleromyography (Device)
结局指标
主要结局
Clinical muscle function tests
时间窗: Muscle function tests are performed immediately after extubation.
Measurement of postoperative residual curarisation with clinical muscle function test: * time able to open the eyes * appearence of diplopic images * time able to stick out the tongue * spatula pressure test * time able to lift the head * time able to lift the arm * strength of the patient pressing the investigator's hand * ability to swallow 20 ml of water
次要结局
- Uncalibrated acceleromyography(Uncalibrated acceleromyography is measured immediately after extubation.)
- Qualitative neuromuscular measurement(Qualitative acceleromyography is measured immediately after extubation.)
研究者
Christoph Unterbuchner
Principal Investigator
University of Regensburg