- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02617433
Relationship Between Muscle Mass and Muscle Relaxation Time
May 2, 2016 updated by: Go Eun Bae
Relationship Between Muscle Mass Measured by Bioelectrical Impedance Analysis and Muscle Relaxation
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.
Study Overview
Detailed Description
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.
Until now, dose of rocuronium has been judged by patient's weight and height.
However, height and weight do not represent exact muscle mass.
The purpose of this study is to find relationship between muscle mass and muscle relaxation time.
Measurement of muscle mass will be obtained using bioelectrical impedence analysis.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 02841
- Korea University Anam Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 64 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- All patient who undergo general anesthesia.
- Male; weight 70-75kg , height 170-175cm
- Female; weight 53-58kg , height 158-163cm
Exclusion Criteria:
- Liver and kidney disease
- Any types of muscle disorder.
- Metal materials or pacemaker in body
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Inbody
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ratio of result of first stimulus(T1) to result of supramaximal stimulation(T0)
Time Frame: two hours
|
T1 and T0 is obtained by train of four which is commonly used neuromuscular monitoring device.
|
two hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
completely suppression time of result of first stimulus(T1).
Time Frame: ten minutes
|
T1 is obtained by train of four which is commonly used neuromuscular monitoring device.
|
ten minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time until reoccurrence of response of first stimulus(T1).
Time Frame: two hours
|
T1 is obtained by train of four which is commonly used neuromuscular monitoring device.
|
two hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Seung Zhoo Yoon, MD, PhD, Korea University Anam Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
November 23, 2015
First Submitted That Met QC Criteria
November 25, 2015
First Posted (Estimate)
December 1, 2015
Study Record Updates
Last Update Posted (Estimate)
May 4, 2016
Last Update Submitted That Met QC Criteria
May 2, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- Inbody
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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