AnesthesiaNCT02657187
The Neuromuscular Effect of Rocuronium in Patient
A study testing Inbody and Rocuronium 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Inbody and Rocuronium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2016to Aug 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patient who undergo general anesthesia
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.
South Korea1 site, 1 recruiting
- Recruiting
Korea university anam hospital
Seoul, 02841
Goeun Bae, M.D., 8229205632, bgecs@naver.com
About this study
Official title: The Neuromuscular Effect of Rocuronium in Patient Measuring Muscle Mass by Bioelectrical Impedance Analysis
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.
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. When the rocuronium was developed, 50% effective dose and 95% effective dose of rocuronium was calculated by patient corrected body weight which used weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.
- Conditions
- Anesthesia
- Being tested
- Inbody, Rocuronium
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, Inbody, Seoul, Korea) after fast for eight hours.
RocuroniumDrug
Also called Esmeron(MSD Korea Ltd.)
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))
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Inbody; Drug: 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). Receives: Device: Inbody; Drug: 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). Receives: Device: Inbody; Drug: 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). Receives: Device: Inbody; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: ten minutes
Secondary outcomes (1)
onset time
time from the end of injection of rocuronium until the maximal depression of T1 which is result of first twitch
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 posted15 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
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
- Go eun Bae, M.D., Study director, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657187
- Sponsor's protocol ID
- Inbody2
- Status last verified
- Feb 2016
- First submitted
- 13 Jan 2016
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuromuscular Effect of Rocuronium in Patient Measuring Muscle Mass by Bioelectrical Impedance Analysis
- ClinicalTrials.gov ID
- NCT02657187
- Acronym / sponsor ID
- Inbody2
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Go Eun BaeUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 15 Jan 2016 (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 50% effective dose and 95% effective dose of rocuronium according to muscle mass.
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. When the rocuronium was developed, 50% effective dose and 95% effective dose of rocuronium was calculated by patient corrected body weight which used weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rocuronium 1 | Experimental | Device: Inbody, Drug: RocuroniumParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.24mg per muscle mass(kg). |
| rocuronium 2 | Experimental | Device: Inbody, Drug: RocuroniumParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.32mg per muscle mass(kg). |
| rocuronium 3 | Experimental | Device: Inbody, Drug: RocuroniumParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.40mg per muscle mass(kg). |
| rocuronium 4 | Experimental | Device: Inbody, Drug: RocuroniumParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.48mg per muscle mass(kg). |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patient who undergo general anesthesia
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, Inbody, Seoul, Korea) after fast for eight hours. | Device | rocuronium 1, rocuronium 2, rocuronium 3, rocuronium 4 |
| RocuroniumAlso: Esmeron(MSD Korea Ltd.)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)) | Drug | rocuronium 1, rocuronium 2, rocuronium 3, rocuronium 4 |
Primary outcome
percentage of neuromuscular block
Time frame: ten minutes
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.
1 secondary outcome
onset time
Time frame: ten minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
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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.
Go eun Bae, M.D. 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 and Rocuronium 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 1 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: status not confirmed, as of the sponsor's last update on 17 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Go eun Bae, M.D. (821047265594, bgecs@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of neuromuscular block (time frame: ten minutes). 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 17 Feb 2016.