NCT02657187

Brief Summary

Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

5 months

First QC Date

January 13, 2016

Last Update Submit

February 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of neuromuscular block

    percentage of neuromuscular block is calculated by ratio of T1 to T4. T1 is result of first stimulation and T4 is result of fourth stimulation which are obtained by commonly used neuromuscular monitoring device.

    ten minutes

Secondary Outcomes (1)

  • onset time

    ten minutes

Other Outcomes (1)

  • lag time

    ten minutes

Study Arms (4)

rocuronium 1

EXPERIMENTAL

Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.24mg per muscle mass(kg).

Device: InbodyDrug: Rocuronium

rocuronium 2

EXPERIMENTAL

Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.32mg per muscle mass(kg).

Device: InbodyDrug: Rocuronium

rocuronium 3

EXPERIMENTAL

Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.40mg per muscle mass(kg).

Device: InbodyDrug: Rocuronium

rocuronium 4

EXPERIMENTAL

Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.48mg per muscle mass(kg).

Device: InbodyDrug: Rocuronium

Interventions

InbodyDEVICE

Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.

rocuronium 1rocuronium 2rocuronium 3rocuronium 4

The individual dose method was used for the determination of the dose response of rocuronium. After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))

Also known as: Esmeron(MSD Korea Ltd.)
rocuronium 1rocuronium 2rocuronium 3rocuronium 4

Eligibility Criteria

Age19 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All patient who undergo general anesthesia

You may not qualify if:

  • Liver and kidney disease
  • Any types of muscle disorder.
  • Metal materials or pacemaker in body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea university anam hospital

Seoul, 02841, South Korea

RECRUITING

MeSH Terms

Interventions

Rocuronium

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Go eun Bae, M.D.

    Korea University Anam Hospital

    STUDY DIRECTOR

Central Study Contacts

Go eun Bae, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical instructor

Study Record Dates

First Submitted

January 13, 2016

First Posted

January 15, 2016

Study Start

February 1, 2016

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

February 17, 2016

Record last verified: 2016-02

Locations