Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium
- Registration Number
- NCT01906528
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Healthy individuals with no current medication -
Previous complications during anesthesia, pregnancy, allergy to muscle relaxants, smoking, gastrointestinal reflux.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Males vs females Mivacurium Constant-rate IV infusions of Mivacurium, range 1.0 - 3 micro/kg/min, duration 150 - 180 min
- Primary Outcome Measures
Name Time Method Pharmacodynamics of Mivacurium 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 Outcome Measures
Name Time Method Clearance of Mivacurium 6 months Clearance calculated as the relationship between steady-state infusion rate of Mivacurium and Mivacurium blood concentration.
Trial Locations
- Locations (1)
University of California, UCSF
🇺🇸San Francisco, California, United States