跳至主要内容
临床试验/NCT05615025
NCT05615025已完成3 期

Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation, in Humans: A Pilot Study

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年1月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
48
试验地点
1
主要终点
Maximum force at the adductor pollicis

研究概览

简要总结

Many drugs have an influence on neuromuscular transmission. In clinical practice, neuromuscular blocking agents are commonly used, but even in the absence of neuromuscular blocking agents, anesthetic drugs can influence neuromuscular transmission. Especially volatile anesthetic agents have a clinical impact on neuromuscular transmission, they have been shown to prolong and deepen the effect of neuromuscular blocking agents. But even in the absence of neuromuscular blocking agents, volatile anesthetics can impair neuromuscular transmission. One mechanism of action is the desensitization of the acetylcholine receptors by shifting them from a normal to a desensitized state. This effect can weaken neuromuscular transmission by reducing the margin of safety that normally exists at the neuromuscular junction, or can cause an apparent increase in the capacity of neuromuscular blocking agents to block transmission.

In this study, the influence of sevoflurane and propofol on the maximum force, maximum speed of contraction and relaxation will be measured at the adductor pollicis in patients having general anesthesia without the use of neuromuscular blocking agents. Maximum force and speed of contraction and relaxation will be measured before and after anesthesia by either sevoflurane or propofol. Primary outcome is the influence of either anesthetic agent on maximum muscular force and speed of contraction - relaxation, and if this influence is greater for volatile anesthetic agents than for intravenous anesthetic agents.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Any pathology involving neuromuscular transmission
  • Confirmed neuropathy of any origin
  • Expected anesthesia duration < 30 min
  • Renal insufficiency defined as a glomerular filtration rate < 40 mL/min/m2
  • Hepatic insufficiency defined as an increase > 1.5 * normal value of hepatic enzymes
  • Confirmed or suspected pregnancy
  • Language barrier
  • Any patient which will receive unplanned neuromuscular blocking agents during surgery
  • Any history of personal or familial suspected malignant hyperthermia

研究组 & 干预措施

Sevoflurane arm

Experimental

In this arm, anesthesia will be maintained by sevoflurane.

干预措施: Sevoflurane (Drug)

Propofol arm

Experimental

In this arm, anesthesia will be maintained by propofol.

干预措施: Propofol (Drug)

结局指标

主要结局

Maximum force at the adductor pollicis

时间窗: 3 hours

Maximum force developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum force developped before and after anesthesia will be compared. The difference in force (Newton) will be measured.

Maximum speed of contraction at the adductor pollicis

时间窗: 3 hours

Maximum speed of contraction developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum speed of contraction developped before and after anesthesia will be compared. The difference in force (Newton/seconds) will be measured.

Maximum speed of relaxation at the adductor pollicis

时间窗: 3 hours

Maximum speed of relaxation developed by a voluntary contraction of the adductor pollicis will be measured during isometric contraction. Maximum speed of relaxation developped before and after anesthesia will be compared. The difference in force (Newton/seconds) will be measured.

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

Denis SCHMARTZ

Anesthesiologists

Université Libre de Bruxelles

研究点 (1)

Loading locations...

相似试验