Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01906528|
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : April 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Muscle Relaxation Sex||Drug: Mivacurium||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacodynamics of Mivacurium in Males and Females: A Study in Human Volunteers|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Males vs females
Constant-rate IV infusions of Mivacurium, range 1.0 - 3 micro/kg/min, duration 150 - 180 min
Effect of Mivacurium in males vs females
Other Name: Mivacron
- 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.
- Clearance of Mivacurium [ Time Frame: 6 months ]Clearance calculated as the relationship between steady-state infusion rate of Mivacurium and Mivacurium blood concentration.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906528
|United States, California|
|University of California, UCSF|
|San Francisco, California, United States, 94131|
|Principal Investigator:||John R Feiner, MD||University of California, UCSF, San Francisco, USA|