Neuromuscular BlockadeNCT06769932
Abdominal Muscle Volume and a Neuromuscular Blocking Agent
An observational study of Neuromuscular Blockade, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
With the recent development of image analysis and artificial intelligence, it has become possible to measure the muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Neuromuscular Blockade
- What is being tested?
- preoperative computed tomography
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2025to 7 Jan 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective colon surgery under general anesthesia
Who may be able to join
- Those who voluntarily agreed and signed the written consent form before participating in the study
- American Society of Anesthesiologists physical class (ASA class) 1-3
- Patients scheduled for elective colon surgery under general anesthesia
- Patients undergoing abdominal computed tomography for routine preoperative preparation
Who cannot join
- Pregnant women
- Decreased renal function (GFR<60mL/min/1.73m2).
- Patients taking drugs that affect deep neuromuscular blockade
- Patients with a history of neuromuscular and muscle disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyunggi-do, 13620
About this study
Official title: Relationship Between Muscle Mass in Preoperative Computed Tomography and a Neuromuscular Blocking Agent Dose Required for Maintaining Deep Neuromuscular Blockage: a Prospective Observational Study.
With the recent development of image analysis and artificial intelligence, it has become possible to measure the muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.
Read the detailed description
Deep neuromuscular blockade improves the condition of surgeon's surgical field during the surgery and reduces the acute postoperative pain. The dosage of neuromuscular blocking agent has been usually administered according to the patient's actual body weight, but even with the same body weight, the ratio of muscle to fat varies from individual to individual, and there are many differences depending on age, gender, and exercise level.
Therefore, if the dose of neuromuscular blocking agent is administered according to actual body weight, additional doses may be required due to insufficient neuromuscular blockade, or excessive doses may occur. However, it was difficult to quantify the muscle mass, with the recent development of image analysis, it has become possible to measure the abdominal muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.
- Conditions
- Neuromuscular Blockade
- Being tested
- preoperative computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative computed tomographyDiagnostic test
subject's muscle mass from preoperative computed tomography (CT) images.
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle volume
subject's muscle volume from preoperative computed tomography images.
Measured: intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start7 Jan 2025 (estimated)
- Primary completion7 Jan 2026 (estimated)
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular BlockadeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park InSun, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769932
- Sponsor's protocol ID
- B-2501-947-305
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Muscle Mass in Preoperative Computed Tomography and a Neuromuscular Blocking Agent Dose Required for Maintaining Deep Neuromuscular Blockage: a Prospective Observational Study.
- ClinicalTrials.gov ID
- NCT06769932
- Acronym / sponsor ID
- B-2501-947-305
- Conditions
- Neuromuscular Blockade
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 7 Jan 2025 (estimated)
- Primary completion
- 7 Jan 2026 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 10 Jan 2025 (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.
With the recent development of image analysis and artificial intelligence, it has become possible to measure the muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.
Detailed description
Deep neuromuscular blockade improves the condition of surgeon's surgical field during the surgery and reduces the acute postoperative pain. The dosage of neuromuscular blocking agent has been usually administered according to the patient's actual body weight, but even with the same body weight, the ratio of muscle to fat varies from individual to individual, and there are many differences depending on age, gender, and exercise level.
Therefore, if the dose of neuromuscular blocking agent is administered according to actual body weight, additional doses may be required due to insufficient neuromuscular blockade, or excessive doses may occur. However, it was difficult to quantify the muscle mass, with the recent development of image analysis, it has become possible to measure the abdominal muscle volume from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the muscle volume from preoperative CT images and analyze the correlation with the dose of neuromuscular blocking agent, rocuronium, required for maintaining deep neuromuscular blockade.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective colon surgery under general anesthesia
Key inclusion criteria (4 listed)
- Those who voluntarily agreed and signed the written consent form before participating in the study
- American Society of Anesthesiologists physical class (ASA class) 1-3
- Patients scheduled for elective colon surgery under general anesthesia
- Patients undergoing abdominal computed tomography for routine preoperative preparation
Key exclusion criteria (4 listed)
- Pregnant women
- Decreased renal function (GFR<60mL/min/1.73m2).
- Patients taking drugs that affect deep neuromuscular blockade
- Patients with a history of neuromuscular and muscle disorders
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 |
|---|---|---|
| preoperative computed tomographysubject's muscle mass from preoperative computed tomography (CT) images. | Diagnostic test | – |
Primary outcome
muscle volume
Time frame: intraoperative period
subject's muscle volume from preoperative computed tomography images.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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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.
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 Neuromuscular Blockade, run by Seoul National University Bundang Hospital 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 10 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Insun Park, M.D./Ph.D. (823178777499, pis121@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle volume (time frame: intraoperative period). 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 10 Jan 2025.