The Neuromuscular Effect of Rocuronium in Patient
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFebruary 17, 2016
February 1, 2016
5 months
January 13, 2016
February 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of neuromuscular block
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 Outcomes (1)
onset time
ten minutes
Other Outcomes (1)
lag time
ten minutes
Study Arms (4)
rocuronium 1
EXPERIMENTALParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.24mg per muscle mass(kg).
rocuronium 2
EXPERIMENTALParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.32mg per muscle mass(kg).
rocuronium 3
EXPERIMENTALParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.40mg per muscle mass(kg).
rocuronium 4
EXPERIMENTALParticipant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) and the dose of rocuronium is 0.48mg per muscle mass(kg).
Interventions
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
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))
Eligibility Criteria
You may qualify if:
- All patient who undergo general anesthesia
You may not qualify if:
- Liver and kidney disease
- Any types of muscle disorder.
- Metal materials or pacemaker in body
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Go Eun Baelead
Study Sites (1)
Korea university anam hospital
Seoul, 02841, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Go eun Bae, M.D.
Korea University Anam Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical instructor
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 15, 2016
Study Start
February 1, 2016
Primary Completion
July 1, 2016
Study Completion
August 1, 2016
Last Updated
February 17, 2016
Record last verified: 2016-02