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临床试验/NCT05716282
NCT05716282招募中不适用

Estimation of Neuromuscular Transmission Recovery After Rocuronium Induced Block - Validation Study of a New Algorithm

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Accuracy of NMB speed of recovery estimation

研究概览

简要总结

Neuromuscular blocking (NMB) agents are used in the vast majority of surgical interventions. Although pharmacokinetic and pharmacodynamic data are available, there is a large interindividual variability in the time needed for recovery after neuromuscular blocking agents. In a previous study (NTC03550664) a mathematical model in order to estimate for each patient the time needed for full recovery based on the first measurable elements of train-of-four (TOF) recovery was established. After the first 14 TOF measurements, the estimated time to reach a recovery of 90%, expressed as % of recovery per 10 min, is calculated.

In this study, this algorithm will be evaluated on a new cohort of patients in order to measure its accuracy and precision. Patients scheduled for surgery with a single dose of 0.6 mg/kg of rocuronium will be included in this prospective observational study. Neuromuscular transmission will be measured at the adductor pollicis using the TOFScan (IdMed, Marseille, France), a CE approved, commercially available monitor for neuromuscular transmission. TOF ratios will be measured every 30 s and recorded on a PC connected to the TOFScan. According to our algorithm, patients will be classified as slow, intermediate or fast recovery; speed of recovery will be measured as % of recovery per 10 min. A McNemar test will be used to assess the correct classification of patients in each group. Accuracy of the estimated speed of recovery will be assessed by comparing to the 95% confidence interval of our model. If real speed of recovery falls within the 95% confidence interval of the model, the model will be classified as accurate. These measurements will be done at 2 time points: - first estimation available and - after TOF ratio has recovered to 40%.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Patients scheduled for surgery with a single bolus administration of 0.6 mg/kg of rocuronium

排除标准

  • patient refusal to participate
  • known or suspected allergy to rocuronium
  • Body mass index < 20 kg/m2
  • Body mass index > 30 kg/m2
  • hepatic insufficiency, either clinical or hepatic test abnormalities
  • renal insufficiency defined as a clearance < 40 mL/min (calculated by the Modification of diet in renal disease (MDRD) formula

结局指标

主要结局

Accuracy of NMB speed of recovery estimation

时间窗: 6 hours

A McNemar test will be used to test the attribution of each patient to one of the groups (slow, intermediate or fast recovery)

Precision of NMB speed of recovery estimation

时间窗: 6 hours

Speed of recovery estimation (% per 10 min) will be considered precise if it falls within the 95% confidence interval boundaries of the model

次要结局

未报告次要终点

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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