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临床试验/NCT04845386
NCT04845386已完成不适用

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

University of Warmia and Mazury in Olsztyn1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年3月25日最近更新:
适应症

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

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

发起方
University of Warmia and Mazury in Olsztyn
申办方类型
Other
责任方
Principal Investigator
主要研究者

Radkowski Paweł MD PhD

Principal Investigator

University of Warmia and Mazury in Olsztyn

研究点 (1)

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