AnesthesiaNCT02617433
Relationship Between Muscle Mass and Muscle Relaxation Time
A study testing Inbody in people with Anesthesia, run by Go Eun Bae at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Inbody
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patient who undergo general anesthesia.
- Male; weight 70-75kg , height 170-175cm
- Female; weight 53-58kg , height 158-163cm
Who cannot join
- Liver and kidney disease
- Any types of muscle disorder.
- Metal materials or pacemaker in body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Inbody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Inbody | Experimental | Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. Receives: Device: Inbody |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two hours
Secondary outcomes (1)
completely suppression time of result of first stimulus(T1).
T1 is obtained by train of four which is commonly used neuromuscular monitoring device.
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Go Eun Bae
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Go Eun Bae, Korea University Anam Hospital
- Investigators
- Seung Zhoo Yoon, MD, PhD, Study director, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617433
- Sponsor's protocol ID
- Inbody
- Status last verified
- May 2016
- First submitted
- 23 Nov 2015
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Muscle Mass Measured by Bioelectrical Impedance Analysis and Muscle Relaxation
- ClinicalTrials.gov ID
- NCT02617433
- Acronym / sponsor ID
- Inbody
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Go Eun BaeUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inbody | Experimental | Device: InbodyParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All patient who undergo general anesthesia.
- Male; weight 70-75kg , height 170-175cm
- Female; weight 53-58kg , height 158-163cm
Key exclusion criteria (3 listed)
- Liver and kidney disease
- Any types of muscle disorder.
- Metal materials or pacemaker in body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InbodyParticipant 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. | Device | Inbody |
Primary outcome
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.
1 secondary outcome
completely suppression time of result of first stimulus(T1).
Time frame: ten minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung Zhoo Yoon, MD, PhD study director
Korea University Anam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inbody in people with Anesthesia, run by Go Eun Bae at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ratio of result of first stimulus(T1) to result of supramaximal stimulation(T0) (time frame: two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.