The Neuromuscular Effect of Rocuronium in Patient

Sponsor

Go Eun Bae (Other)

Overall Status

Unknown status

CT.gov ID

NCT02657187

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

13.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: Inbody Drug: Rocuronium	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.)

Outcome Measures

Primary Outcome Measures

percentage of neuromuscular block [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.

Secondary Outcome Measures

onset time [ten minutes]
time from the end of injection of rocuronium until the maximal depression of T1 which is result of first twitch

Other Outcome Measures

lag time [ten minutes]
time from the end of injection of rocuronium until the first depression of the twitch response

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea university anam hospital	Seoul		Korea, Republic of	02841

Sponsors and Collaborators

Go Eun Bae

Investigators

Study Director: Go eun Bae, M.D., Korea University Anam Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Go Eun Bae, Clinical instructor, Korea University Anam Hospital

ClinicalTrials.gov Identifier:

NCT02657187

Other Study ID Numbers:

Inbody2

First Posted:

Jan 15, 2016

Last Update Posted:

Feb 17, 2016

Last Verified:

Feb 1, 2016

Additional relevant MeSH terms:

Rocuronium

Study Results

No Results Posted as of Feb 17, 2016