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临床试验/NCT04965532
NCT04965532Unknown不适用

Second Affiliated Hospital Zhejiang University School of Medicine

Second Affiliated Hospital, School of Medicine, Zhejiang University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Muscle relaxation recovery index

研究概览

简要总结

Chemotherapy causes motor nerve dysfunction and degeneration that may alter the response to neuromuscular blocking drugs. To analyse the risk of residual neuromuscular block (RNMB) induced by rocuronium given in standard doses to patients who undergo chemotherapy within three months.

详细描述

Rocuronium, as a non depolarizing muscle relaxant with medium time effect, takes effect rapidly. It is an ideal neuromuscular blocker to replace succinylcholine for induction of tracheal intubation and maintenance of muscle relaxant under general anesthesia. Sevoflurane is widely used in clinic because of its low blood gas partition coefficient, rapid and stable induction and recovery, easy adjustment of anesthesia depth and strong controllability. In addition, the number of patients receiving preoperative adjuvant chemotherapy for malignant tumors is increasing year by year in China. The commonly used chemotherapy drugs, such as paclitaxel, platinum, vinorelbine, etc., have dose-dependent peripheral neurotoxicity. Therefore, to explore and study the influence of pathophysiological changes of patients receiving chemotherapy on the neuromuscular relaxation effect of sevoflurane combined with non depolarizing neuromuscular blockers, It is very important for anesthesia, resuscitation and perioperative management of chemotherapy patients. The purpose of this study is to reveal the effect of sevoflurane on rocuronium neuromuscular blockade in chemotherapy patients by comparing the difference of rocuronium neuromuscular blockade effect of sevoflurane and total intravenous anesthesia in chemotherapy patients and non chemotherapy patients, and to provide information for more safe and rational application of rocuronium in clinical anesthesia of chemotherapy patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients classified as American Society of Anesthesiology physical status (ASA PS) classes I, II or III
  • Aged between 18 and 70 years
  • Scheduled for radiofrequency ablation of liver tumours under general anaesthesia with an expected surgery duration shorter than 60min

排除标准

  • Allergy to rocuronium
  • Myasthenia gravis
  • Guillain-Barre ́ syndrome
  • Duchenne muscular dystrophy or similar
  • Receiving drugs that might interfere with the neuromuscular transmission or the response to neuromuscular blockers, such as some anticonvulsants and antibiotics

研究组 & 干预措施

nonchemotherapy patients using sevoflurane anesthesia

Active Comparator

Following induction of anesthesia and laryngeal mask placement, anesthesia will be maintained by inhalation of sevoflurane (approximately 1.3 × minimum alveolar concentration) and IV fentanyl according to clinical need.

干预措施: sevoflurane anesthesia (Drug)

chemotherapy patients using sevoflurane anesthesia

Experimental

Following induction of anesthesia and laryngeal mask placement, anesthesia will be maintained by inhalation of sevoflurane (approximately 1.3 × minimum alveolar concentration) and IV fentanyl according to clinical need.

干预措施: sevoflurane anesthesia (Drug)

chemotherapy patients using total intravenous anesthesia

Active Comparator

Following induction of anesthesia and laryngeal mask placement, maintenance of anesthesia will consist of target-controlled infusion of propofol at a plasma target concentration of 1.5-3.0µg/ml and IV fentanyl according to clinical need.

干预措施: Propofol Injection (Drug)

nonchemotherapy patient using total intravenous anesthesia

Active Comparator

Following induction of anesthesia and laryngeal mask placement, maintenance of anesthesia will consist of target-controlled infusion of propofol at a plasma target concentration of 1.5-3.0µg/ml and IV fentanyl according to clinical need.

干预措施: Propofol Injection (Drug)

结局指标

主要结局

Muscle relaxation recovery index

时间窗: The first 90 min following intravenous injection of rocuronium

Time interval from 25% recovery to 75% recovery of the first twitch in the TOF stimulation pattern

次要结局

  • Onset time of muscle relaxation(The first 90 min following intravenous injection of rocuronium)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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