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临床试验/NCT01906528
NCT01906528已完成1 期

The Pharmacodynamics of Mivacurium in Males and Females: A Study in Human Volunteers

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
20
试验地点
1
主要终点
Pharmacodynamics of Mivacurium

研究概览

简要总结

Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous studies have shown that males and females respond differently to this kind of drug. Our hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant) than females, meaning that males need a lower blood concentration of the drug than females in order to obtain a given effect.

详细描述

Muscle relaxants are a type of drug used to provide muscle relaxation during induction of anesthesia and surgical treatment. Residual drug effect postoperatively (i.e. residual muscle relaxation) occurs frequently and studies have shown that this may be harmful in certain groups of patients. Of special concern is residual effect on upper airway and breathing muscles. A previous study has shown that males and females respond differently to the effect of this kind of drug. It appears that some muscle groups which are important for airway protection and breathing are more sensitive to the effect of muscle relaxants in males than females. Males may therefore be more susceptible to postoperative lung complications than females. In this study we try to determine what causes the observed sex-related difference in response to the muscle relaxant Mivacurium. We have previously shown that this sex-related difference cannot be explained by different pharmacokinetics (what the body does to the drug) in males and females. Our hypothesis is that a pharmacodynamic (what the drug does to the body) difference between sexes exists, i.e. that a lower blood concentration of Mivacurium is needed in males than females in order to obtain a predefined degree of muscle relaxation in certain muscle groups.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy individuals with no current medication -

排除标准

  • Previous complications during anesthesia, pregnancy, allergy to muscle relaxants, smoking, gastrointestinal reflux.

研究组 & 干预措施

Males vs females

Experimental

Constant-rate IV infusions of Mivacurium, range 1.0 - 3 micro/kg/min, duration 150 - 180 min

干预措施: Mivacurium (Drug)

结局指标

主要结局

Pharmacodynamics of Mivacurium

时间窗: 6 months

The mivacurium drug concentration in the blood associated with 50% of maximal drug effect at steady-state conditions (Css50) will be determined at the thumb and the handgrip muscles.

次要结局

  • Clearance of Mivacurium(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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