Relationship Between Muscle Mass and Muscle Relaxation Time

Anesthesia Clinical Trial

Official title:

Relationship Between Muscle Mass Measured by Bioelectrical Impedance Analysis and Muscle Relaxation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617433
• Other study ID #: Inbody
• Status: Completed
• Phase: N/A
• First received: November 23, 2015
• Last updated: May 2, 2016
• Start date: December 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 relationship between muscle mass and muscle relaxation time.

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. However, height and weight do not represent exact muscle mass. The purpose of this study is to find relationship between muscle mass and muscle relaxation time. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 64 Years

Eligibility

Inclusion Criteria:

• All patient who undergo general anesthesia.

• Male; weight 70-75kg , height 170-175cm

• Female; weight 53-58kg , height 158-163cm

Exclusion Criteria:

• Liver and kidney disease

• Any types of muscle disorder.

• Metal materials or pacemaker in body

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Inbody
Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. After measurement, patient is induced anesthesia. Rocuronium dose is 12mg for male, and 9mg for female.

Locations

Country	Name	City	State
Korea, Republic of	Korea university anam hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Go Eun Bae

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time until reoccurrence of response of first stimulus(T1).	T1 is obtained by train of four which is commonly used neuromuscular monitoring device.	two hours	No
Primary	ratio of result of first stimulus(T1) to result of supramaximal stimulation(T0)	T1 and T0 is obtained by train of four which is commonly used neuromuscular monitoring device.	two hours	No
Secondary	completely suppression time of result of first stimulus(T1).	T1 is obtained by train of four which is commonly used neuromuscular monitoring device.	ten minutes	No