RocuroniumNCT05515835
Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
An observational study of Rocuronium and Body Composition, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rocuronium, Body Composition
- What is being tested?
- body composition analysis
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 88 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2022to Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with ASA class I-II undergoing total intravenous general anesthesia
Who may be able to join
- Adult patients with ASA class I-II undergoing total intravenous general anesthesia
Who cannot join
- too overweight (over 111.11kg, which corresponds to less than 0.45mg/kg of induction dose of rocuronium)
- too underweight (under 41.67kg, which corresponds to more than 1.2mg/kg of induction dose of rocuronium)
- pregnancy
- prediagnosed muscle or nerve related disease
- unsuitable for body composition analysis using bioelectrical impedance method
- unsuitable for neuromuscular block monitoring
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University, School of Medicine
Seoul, 06351
About this study
The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Therefore, we plan to analyse body composition in patients undergoing total intravenous general anesthesia, give the patients a fixed dose (50mg) of rocuronium, and check the correlation between duration time of rocuronium and body composition analysis data.
- Conditions
- Rocuronium, Body Composition
- Being tested
- body composition analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
body composition analysisDevice
Patients will undergo body composition analysis using bioelectical impedance method before anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| rocuronium | The patient will be given 50mg of rocuronium intravenously for induction. Receives: Device: body composition analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to TOF1
correlation between the time from induction to recovery of 1st TOF twitch and age, sex, ASA class, body weight, and body composition analysis data
Measured: up to 1 hour after rocuronium administration during induction of anesthesia
time to TOF4
correlation between the time from induction to recovery of 4th TOF twitch and age, sex, ASA class, body weight, and body composition analysis data
Measured: up to 1.5 hour after rocuronium administration during induction of anesthesia
Secondary outcomes (1)
time to loss of TOF
correlation between the time from injection of rocuronium to complete loss of TOF twitch and age, sex, ASA class, body weight, and body composition analysis data
Measured: up to 5 minutes after rocuronium administration during induction of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start5 Sep 2022
- Primary completion30 Dec 2022
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RocuroniumStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Hwan Lee, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515835
- Sponsor's protocol ID
- SMC 2022-07-160
- Status last verified
- Jan 2023
- First submitted
- 22 Aug 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
- ClinicalTrials.gov ID
- NCT05515835
- Acronym / sponsor ID
- SMC 2022-07-160
- Conditions
- Rocuronium, Body Composition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- Mar 2023 (estimated)
- First posted
- 25 Aug 2022 (actual)
- 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.
The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Therefore, we plan to analyse body composition in patients undergoing total intravenous general anesthesia, give the patients a fixed dose (50mg) of rocuronium, and check the correlation between duration time of rocuronium and body composition analysis data.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rocuronium | – | Device: body composition analysisThe patient will be given 50mg of rocuronium intravenously for induction. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with ASA class I-II undergoing total intravenous general anesthesia
Key inclusion criteria (1 listed)
- Adult patients with ASA class I-II undergoing total intravenous general anesthesia
Key exclusion criteria (6 listed)
- too overweight (over 111.11kg, which corresponds to less than 0.45mg/kg of induction dose of rocuronium)
- too underweight (under 41.67kg, which corresponds to more than 1.2mg/kg of induction dose of rocuronium)
- pregnancy
- prediagnosed muscle or nerve related disease
- unsuitable for body composition analysis using bioelectrical impedance method
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 |
|---|---|---|
| body composition analysisPatients will undergo body composition analysis using bioelectical impedance method before anesthesia. | Device | rocuronium |
Primary outcome
time to TOF1
Time frame: up to 1 hour after rocuronium administration during induction of anesthesia
correlation between the time from induction to recovery of 1st TOF twitch and age, sex, ASA class, body weight, and body composition analysis data
time to TOF4
Time frame: up to 1.5 hour after rocuronium administration during induction of anesthesia
correlation between the time from induction to recovery of 4th TOF twitch and age, sex, ASA class, body weight, and body composition analysis data
1 secondary outcome
time to loss of TOF
Time frame: up to 5 minutes after rocuronium administration during induction of anesthesia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Rocuronium
RecruitingPhase 4
Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation
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Not yet recruitingPhase 2
A Dose-Finding Study of Amogammadex Sodium for Reversing Vecuronium and Rocuronium-Induced Neuromuscular Blockade
Reversing Vecuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery, Reversing Rocuronium-Induced Neuromuscular Blockade in Patients Undergoing General Anesthesia Surgery
Not yet recruitingPhase 4
Developing a Physiology-Pharmacodynamic Model of Rocuronium Dose and Cardiac Output to Investigate the Onset Time of Neuromuscular Relaxation
Induction of Anaesthesia, Muscle Relaxants
Not yet recruitingPhase 4
Lidocaine, Paracetamol, and Dexmedetomidine for Rocuronium Injection Pain
Propofol Injection Pain, Rocuronium Injection Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rocuronium and Body Composition, run by Samsung Medical Center 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 6 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 4 Jan 2023. 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?
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?
time to TOF1 (time frame: up to 1 hour after rocuronium administration during induction of anesthesia). The study lists 2 primary outcomes in all. 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 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.