Skip to main content
OpenTrials
Completed

NCT Number: NCT01906528

Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, UCSF

San Francisco, California, 94131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy individuals with no current medication -

Exclusion criteria

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

-

Treatment and study plan

Mivacurium

Drug

Effect of Mivacurium in males vs females

Other names: Mivacron

Primary outcomes

  1. Pharmacodynamics of Mivacurium

    Time frame: 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.

Secondary outcomes

  1. Clearance of Mivacurium

    Time frame: 6 months

    Clearance calculated as the relationship between steady-state infusion rate of Mivacurium and Mivacurium blood concentration.

Other outcomes

  1. Relationship between thumb acceleration (TOF ratio) and handgrip strength in both sexes

    Time frame: 6 months

    Thumb acceleration secondary to nerve stimulation at the ulnar nerve (TOF ratio) is an objective way of monitoring the effect of muscle relaxants that is used frequently during clinical anesthesia. Handgrip strength will be monitored with a dynamometer.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Oslo University Hospital

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 24, 2013
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.