Clinical trial NCT01906528: Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium
Official title: The Pharmacodynamics of Mivacurium in Males and Females: A Study in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Muscle Relaxation
Sex
Keywords: Nondepolarizing neuromuscular blocking drug
Mivacurium
Sensitivity
Sex
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2013-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria: Healthy individuals with no current medication -

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

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Primary outcomes:
measure: Pharmacodynamics of Mivacurium
timeFrame: 6 months
Secondary outcomes:
measure: Clearance of Mivacurium
timeFrame: 6 months
Other outcomes:
measure: Relationship between thumb acceleration (TOF ratio) and handgrip strength in both sexes
timeFrame: 6 months
Locations:
city: San Francisco
country: United States
facility: University of California, UCSF
state: California
Study officials:
affiliation: University of California, UCSF, San Francisco, USA
name: John R Feiner, MD
role: PRINCIPAL_INVESTIGATOR
References: