NCT02617433

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 relationship between muscle mass and muscle relaxation time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

November 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

November 23, 2015

Last Update Submit

May 2, 2016

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • ratio of result of first stimulus(T1) to result of supramaximal stimulation(T0)

    T1 and T0 is obtained by train of four which is commonly used neuromuscular monitoring device.

    two hours

Secondary Outcomes (1)

  • completely suppression time of result of first stimulus(T1).

    ten minutes

Other Outcomes (1)

  • Time until reoccurrence of response of first stimulus(T1).

    two hours

Study Arms (1)

Inbody

EXPERIMENTAL

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

Device: Inbody

Interventions

InbodyDEVICE

Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. After measurement, patient is induced anesthesia. Rocuronium dose is 12mg for male, and 9mg for female.

Inbody

Eligibility Criteria

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

You may qualify if:

  • All patient who undergo general anesthesia.
  • Male; weight 70-75kg , height 170-175cm
  • Female; weight 53-58kg , height 158-163cm

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

Location

Study Officials

  • Seung Zhoo Yoon, MD, PhD

    Korea University Anam Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical instructor

Study Record Dates

First Submitted

November 23, 2015

First Posted

December 1, 2015

Study Start

December 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

KR(1)