跳至主要内容
临床试验/NCT03737942
NCT03737942Unknown不适用

Effect of Type II Diabetes Mellitus With Neuropathy on the Clinical Use of Rocuronium: A Pharmacodynamic Modelling Study

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
neuromuscular monitoring

研究概览

简要总结

International Diabetes Federation estimates that there are now 415 million adults aged 20-79 with diabetes mellitus worldwide. By 2040 this will rise to 640 million. Although diabetes mellitus is highly prevalent in our environment and one of the most important challenges of modern medicine, only a handful of studies have examined the neuromuscular function in diabetic patients. The shortage of publications in this area is still more surprising if we consider that the neuromuscular blockers are one of the pillars in the administration of general anesthesia. Neuromuscular blockers during surgery are used in tracheal intubation and to improve surgical conditions.

详细描述

In diabetic patients, neuropathy, microvascular and macrovascular complications are known clinical findings which require attention during anesthesia. Partial degeneration or segmental demyelination of the nerve fibers and loss of motor units have been reported in patients with diabetes mellitus as well. Therefore, the effects of a neuromuscular blocking agent should be important because of potential complications from incomplete reversal or residual paralysis during anesthesia maintenance. In a series of studies, vecuronium has been the only agent investigated in patients with diabetes mellitus and other diseases characterized by neuromuscular dysfunction. Delayed recovery from the neuromuscular block after vecuronium administration was shown in patients with diabetes mellitus. Currently, rocuronium, with its rapid onset of action, rapid recovery profile and inactive metabolites, is generally known as a safe agent for anesthesia under normal conditions. It is known that the pharmacokinetic properties of rocuronium can be altered in some diseases, such as renal or hepatic failure. However, it has not been investigated whether the effect of rocuronium on neuromuscular function is changed in the presence of neuropathy in diabetes mellitus patients or not. The rationale of our study arises from the finding of many studies that show different changes in the neurophysiological parameters in diabetes mellitus. In diabetic nerve, the conduction velocity of the action potential is decreased, the amplitude of action potentials, both sensory and motor, is smaller, and the latency time is elongated.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients aged from 18 years to 65 years.
  • scheduled for abdominal surgery under general anesthesia

排除标准

  • Patients with allergy to rocuronium
  • those diagnosed with diseases that alter neuromuscular blocker response (e.g., Guillain-Barré syndrome, Duchenne type muscle dystrophies, etc.),
  • patients receiving treatment with drugs capable of altering neuromuscular transmission or neuromuscular blocker response (e.g., antiseizure drugs, certain antibiotics, etc.).

结局指标

主要结局

neuromuscular monitoring

时间窗: before operation,till one hour

Tetanic stimulus , 50 Hz during 5 seconds (tetanic preconditioning).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Mohammed AboelFadl

principal investigator

Assiut University

研究点 (1)

Loading locations...

相似试验