NCT01906528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

4 months

First QC Date

July 17, 2013

Last Update Submit

April 9, 2014

Conditions

Muscle RelaxationSex

Keywords

Nondepolarizing neuromuscular blocking drugMivacuriumSensitivitySex

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamics of Mivacurium

    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.

    6 months

Secondary Outcomes (1)

  • Clearance of Mivacurium

    6 months

Other Outcomes (1)

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

    6 months

Study Arms (1)

Males vs females

EXPERIMENTAL

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

Drug: Mivacurium

Interventions

MivacuriumDRUG

Effect of Mivacurium in males vs females

Also known as: Mivacron
Males vs females

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, UCSF

San Francisco, California, 94131, United States

Location

MeSH Terms

Conditions

CoitusHypersensitivity

Interventions

Mivacurium

Condition Hierarchy (Ancestors)

Sexual BehaviorBehaviorImmune System Diseases

Intervention Hierarchy (Ancestors)

IsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • John R Feiner, MD

    University of California, UCSF, San Francisco, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2013

First Posted

July 24, 2013

Study Start

March 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

US(1)