Neuromuscular Blockade Monitoring Using Kine-myography vs Electromyography in Patients Undergoing General Anaesthesia With the Use of Rocuronium and Cis-atracurium.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Measurement variability
研究概览
简要总结
This study aims to compare two monitoring methods of neuromuscular blockade - Kine-myography and Electromyography.
The main questions to answer are:
- are electromyography and kine-myography interchangeable
- is electromyography linked to fewer fault results
- is electromyography using lower energy to stimulate nerves
The type of study is a multicentric observational clinical trial. Subjects are patients undergoing general anaesthesia with the use of rocuronium or cis-atracurium. In each patient, the neuromuscular blockade will be monitored using kine-myograph and electromyography simultaneously.
详细描述
Informed consent will first be obtained from the patient for inclusion in the study. Consent will be obtained during an examination by the anaesthesiologist providing anaesthetic care during surgery in the anteroom of the operating theatre.
Once informed consent has been obtained, a routine orientation examination will be performed by the anaesthetist and routine pre-operative preparation (provision of peripheral venous access, risk assessment for airway obstruction, etc.) will be performed. The patient will then be transported to the operating theatre.
In the operating room, patient monitoring will be initiated, including the deployment of sensors to monitor the depth of neuromuscular blockade. The KMG sensor will be placed on the right arm and the EMG sensor on the left arm. After deployment of the sensors, upper limb fixation will be performed by the anaesthetic nurse. The fixation will be performed with splints compatible with the operating table. Fixation of the limbs and sensor with adhesive tape will not be used.
The anaesthesia will then be induced. Propofol and sufentanil will be administered at the discretion of the anaesthetist providing anaesthetic care. Once sufficient depth of sedation has been induced, calibration of the sensors monitoring the depth of neuromuscular blockade will be performed. After calibration of the sensors, the supramaximal current to the CRF will be recorded. The measurement interval will be set to 20 s. After securing the airway, the interval will be extended to 5 - 15 min according to the nature of the surgery and the discretion of the anaesthesiologist providing anaesthetic care. The number of twitches (PCT) and the Train Of Four (TOF) value will be recorded throughout the procedure.
On emergence from anaesthesia, the measurement interval will be set to 1 minute. Once sufficient depth of neuromuscular blockade has been reached to allow extubation, monitoring of the depth of neuromuscular blockade will be discontinued.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing surgery under general anaesthesia with the use of cis-atracurium or rocuronium
排除标准
- •patients suffering from neuromuscular diseases
- •patients with known allergy to rocuronium or cis-atracurium
- •patients in whom it is impossible to measure the depth of the neuromuscular block on the upper extremities (injuries of the upper extremities, contractures etc.)
- •patients undergoing surgery positioned on their side
- •patients with an upper arm injury
- •patients with acromegaly
- •patients with Alzheimer's disease
- •patients with the risk of difficult airways
- •patients induced into general anaesthesia via the Rapid Sequence Induction method
- •patients with a weight under 5 kilograms
结局指标
主要结局
Measurement variability
时间窗: From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.
A primary aim is to demonstrate that measurement of the depth of neuromuscular blockade using kinemyography is associated with a higher measurement variability than measurement of the depth of neuromuscular blockade using electromyography.
次要结局
- TOF overestimation(From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.)
- supramaximal electric stimulus(From sensor calibration til extubation at TOF higher than 90%.Maximum length of measurement is 6 hours.)
研究者
Michal Kalina
principal investigator
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.