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The Neuromuscular Effect of Rocuronium in Patient

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ClinicalTrials.gov Identifier: NCT02657187
Recruitment Status : Unknown
Verified February 2016 by Go Eun Bae, Korea University Anam Hospital.
Recruitment status was:  Recruiting
First Posted : January 15, 2016
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Go Eun Bae, Korea University Anam Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesia Device: Inbody Drug: Rocuronium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: Esmeron(MSD Korea Ltd.)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. lag time [ Time Frame: ten minutes ]
    time from the end of injection of rocuronium until the first depression of the twitch response



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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657187


Contacts
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Contact: Go eun Bae, M.D. 821047265594 bgecs@naver.com

Locations
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Korea, Republic of
Korea university anam hospital Recruiting
Seoul, Korea, Republic of, 02841
Contact: Goeun Bae, M.D.    8229205632    bgecs@naver.com   
Sponsors and Collaborators
Go Eun Bae
Investigators
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Study Director: Go eun Bae, M.D. Korea University Anam Hospital

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Responsible Party: Go Eun Bae, Clinical instructor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT02657187     History of Changes
Other Study ID Numbers: Inbody2
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Agents
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs