Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.

January 2, 2023 updated by: Jong Hwan Lee, Samsung Medical Center
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

88

Contacts and Locations

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

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center, Sungkyunkwan University, School of Medicine

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with ASA class I-II undergoing total intravenous general anesthesia

Description

Inclusion Criteria:

  • Adult patients with ASA class I-II undergoing total intravenous general anesthesia

Exclusion Criteria:

  • 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

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
rocuronium
The patient will be given 50mg of rocuronium intravenously for induction.
Device: body composition analysis
Patients will undergo body composition analysis using bioelectical impedance method before anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 1 hour after rocuronium administration during induction of anesthesia
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
up to 1.5 hour after rocuronium administration during induction of anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to loss of TOF
Time Frame: up to 5 minutes after rocuronium administration during induction of anesthesia
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
up to 5 minutes after rocuronium administration during induction of anesthesia

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

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 (Actual)

September 5, 2022

Primary Completion (Actual)

December 30, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 25, 2022

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • SMC 2022-07-160

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

Clinical Trials on Body Composition

Clinical Trials on body composition analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe