Abdominal Muscle Volume and a Neuromuscular Blocking Agent

January 6, 2025 updated by: Park InSun, Seoul National University Bundang Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyunggi-do
      • Seongnam-si, Gyunggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for elective colon surgery under general anesthesia

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle volume
Time Frame: intraoperative period
subject's muscle volume from preoperative computed tomography images.
intraoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang 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 (Estimated)

January 7, 2025

Primary Completion (Estimated)

January 7, 2026

Study Completion (Estimated)

January 7, 2027

Study Registration Dates

First Submitted

January 6, 2025

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • B-2501-947-305

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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