The Neuromuscular Effect of Rocuronium in Patient

February 14, 2016 updated by: Go Eun Bae

The Neuromuscular Effect of Rocuronium in Patient Measuring Muscle Mass by Bioelectrical Impedance Analysis

Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. Until now, dose of rocuronium has been judged by patient's weight and height. When the rocuronium was developed, 50% effective dose and 95% effective dose of rocuronium was calculated by patient corrected body weight which used weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patient who undergo general anesthesia

Exclusion Criteria:

  • Liver and kidney disease
  • Any types of muscle disorder.
  • Metal materials or pacemaker in body

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: rocuronium 1
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.24mg per muscle mass(kg).
Device: Inbody
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
Drug: Rocuronium
The individual dose method was used for the determination of the dose response of rocuronium. After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Other Names:
  • Esmeron(MSD Korea Ltd.)
Experimental: rocuronium 2
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.32mg per muscle mass(kg).
Device: Inbody
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
Drug: Rocuronium
The individual dose method was used for the determination of the dose response of rocuronium. After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Other Names:
  • Esmeron(MSD Korea Ltd.)
Experimental: rocuronium 3
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.40mg per muscle mass(kg).
Device: Inbody
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
Drug: Rocuronium
The individual dose method was used for the determination of the dose response of rocuronium. After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Other Names:
  • Esmeron(MSD Korea Ltd.)
Experimental: rocuronium 4
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.48mg per muscle mass(kg).
Device: Inbody
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
Drug: Rocuronium
The individual dose method was used for the determination of the dose response of rocuronium. After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
Other Names:
  • Esmeron(MSD Korea Ltd.)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
percentage of neuromuscular block
Time Frame: ten minutes
percentage of neuromuscular block is calculated by ratio of T1 to T4. T1 is result of first stimulation and T4 is result of fourth stimulation which are obtained by commonly used neuromuscular monitoring device.
ten minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
onset time
Time Frame: ten minutes
time from the end of injection of rocuronium until the maximal depression of T1 which is result of first twitch
ten minutes

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
lag time
Time Frame: ten minutes
time from the end of injection of rocuronium until the first depression of the twitch response
ten minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Go Eun Bae

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Go eun Bae, M.D., Korea University Anam 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Inbody2

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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