A Comparison of Neuromuscular Transmission in the Arm and Hand Muscles With Alternative Muscles Such as the Lower Leg Muscles and the Corrugator Supercilii During General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Onset time
研究概览
简要总结
The investigators want to compare new muscle relaxation monitoring, TOF-Cuff and TOF-Scan, during general anesthesia. Standard monitoring is using thumb, however it can't be use on every patient. Alternative can be eyebrow muscle or foot muscle.
There is only few old study that compares this muscle and used mivacurium. The study aims to compare TOF-Cuff and TOF-Scan with different sensor and use mivacurium.
详细描述
In our research in addition to the standard intraoperative monitoring, which includes the assessment of ECG and saturation, the investigators would like to estimate muscle relaxation by using two different methods: a TOF-Cuff which additionally allows to measure inoperative blood pressure and TOF-Scan with different sensor. Our aim is to compare two different methods of muscle relaxation monitoring in patients who will administer muscle relaxant - mivacurium. After receiving painkillers and hypnotics, when the patient is falling asleep, the standard dose of mivacurium 0.2 mg / kg body weight will be administered. Then, painless simultaneous stimulation with TOF-Cuff and TOF-Scan devices will begin. Until intubation, measurements will be made in every 30 seconds and then every 5 minutes until extubation. Extubation will take place according to the guidelines when the TOF-Cuff measurement on the arm is greater than 0.9 - this is the value at which the patient is considered ready to start breathing on his own. The following will be documented: the initiation of drug administration, intubation, possible repeated doses of mivacurium 2 mg, antagonization, extubation, possible side effects (e.g., transient cardiac disturbances, reddening of the skin, lowering blood pressure, bronchospasm, erythema, urticaria) and technical problems.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75
- •ASA classification I,II,III
- •Elective surgery
- •BMI(body mass index) 17-35
- •Surgery in the supine position
- •Informed consent of the patient
排除标准
- •Pregnancy and breastfeeding
- •Urgent indications for surgery
- •ASA classification >III
- •Neuromuscular diseases
- •Polyneuropathy
- •Drug addiction
- •Family history of malignant hyperthermia
- •Allergic to propofol, fentanyl or mivacurium
结局指标
主要结局
Onset time
时间窗: 1 to 10 minutes
Time in seconds from start of injection of mivacurium until emergence of TOF ratio of 0%. TOF = Train of Four
Total recovery time of neuromuscular block
时间窗: 30 to 500 minutes
The total recovery time, i.e. total duration of the neuromuscular block is defined as the time in minutes from start of injection of mivacurium until a normalized TOF ratio of 90%
次要结局
- Time to repeated dose(5 to 200 minutes)
研究者
Radkowski Paweł MD PhD
Principal Investigator
University of Warmia and Mazury in Olsztyn
