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临床试验/NCT04760912
NCT04760912已完成4 期

Comparison of General Anesthesia With Use of Muscle Relaxation and General Anesthesia Without Muscle Relaxation on Recovery of Muscle Strength of the Patients

Clinical Hospital Centre Zagreb1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Muscle strenght recovery after general anesthesia

研究概览

简要总结

Neuromuscular blocking agents are often used during general anesthesia. Also, general anesthesia may be performed without use of neuromuscular blocking agents.

Avoiding neuromuscular relaxation enables better muscle strength recovery.

详细描述

Rocuronium is well used neuromuscular blocking agent during general anesthesia. Although very often used, neuromuscular blocking agents may sometimes have consequence in form of residual neuromuscular block.

Tha aim of the study is to compare influence of rocuronium during general anesthesia on muscle strength recovery measured by hand grip dynamometer. Measuremwnt of hand grip strength is perforrmed before and after general anesthesia. This research should contribute to better choice of anesthesia technique and better quality of patient recovery, as studies so far have not been detaily carried out.

Hypothesis of the research is that anesthesia without use of neuromuscular blocking agents may enable better recovery of muscle strength in immediate postoperative period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

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

  • patients ASA status I-III for surgery under general anesthesia
  • signed informed consent for participating in research

排除标准

  • neuromuscular disease
  • poorly controled chronic or acute cardiovascular, respiratory or autoimmune disease
  • known allergic reaction to any medication used in this research
  • pregnancy
  • refusal to participate in this research

研究组 & 干预措施

Experimental group general anesthesia without rocuronium

Experimental

30 patient ASA classification 1-2 for general anesthesia. Standard anesthesia monitoring. After induction with Propofol and Sufentanil ( doses adjusted according to weight and age) anesthesia was maintained with sevorane. Muscle strength measured on three occasions with Yamar dinamometar for hand grip strength, before induciran to anesthesia and immediate after Salingeru from anesthesia, then again measured in first 24 hours.

干预措施: General anesthesia for surgery (Procedure)

Active comparator: general anesthesia with rocuronium

Active Comparator

30 patient ASA classification 1-2 for general anesthesia. Standard anesthesia monitoring with train-of-four (TOF). After induction with Propofol and Sufentanil (doses adjusted according to weight and age) and rocuronium 0,6 mg per kg, anesthesia maintained with sevorane. Muscle strength neasured with Yamar dinamometar for hand grip strength before induction to anesthesia and immediate after awakening from anesthesia, then again measured in first 24 hours.

干预措施: Rocuronium (Drug)

Active comparator: general anesthesia with rocuronium

Active Comparator

30 patient ASA classification 1-2 for general anesthesia. Standard anesthesia monitoring with train-of-four (TOF). After induction with Propofol and Sufentanil (doses adjusted according to weight and age) and rocuronium 0,6 mg per kg, anesthesia maintained with sevorane. Muscle strength neasured with Yamar dinamometar for hand grip strength before induction to anesthesia and immediate after awakening from anesthesia, then again measured in first 24 hours.

干预措施: General anesthesia for surgery (Procedure)

结局指标

主要结局

Muscle strenght recovery after general anesthesia

时间窗: Perioperative

Change in muscle strength recovery measured with hand grip dynamometer after general anesthesia with or without rocuronium. Better understanding of mechanism how neuromuscular blockade influences quality if patient recovery due to muscle strength recovery

次要结局

未报告次要终点

研究者

发起方
Clinical Hospital Centre Zagreb
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martina Miklic Bublic, MD, PhD

Principal investigator

Clinical Hospital Centre Zagreb

研究点 (1)

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