Skeletal Muscle Index and a Neuromuscular Blocking Agent

December 13, 2024 updated by: Park InSun, Seoul National University Bundang Hospital

Relationship Between Skeletal Muscle Index 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, it has become possible to measure the skeletal muscle index representing the subject's muscle mass from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the skeletal muscle index 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

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 skeletal muscle index representing the subject's muscle mass from preoperative computed tomography (CT) images. Therefore, in this study, the investigators quantify the skeletal muscle index 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

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

N/A

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
Skeletal Muscle index
Time Frame: preoperative period
Muscle amount
preoperative period

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Insun Park, M.D./Ph.D., Assistant Professor

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)

December 25, 2024

Primary Completion (Estimated)

December 25, 2025

Study Completion (Estimated)

December 25, 2026

Study Registration Dates

First Submitted

December 13, 2024

First Submitted That Met QC Criteria

December 13, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 13, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • B-2501-947-303

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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