The Neuromuscular Effect of Rocuronium in Patient

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02657187
• Other study ID #: Inbody2
• Status: Recruiting
• Phase: N/A
• First received: January 13, 2016
• Last updated: February 14, 2016
• Start date: February 2016
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Korea University Anam Hospital
• Contact: Go eun Bae, M.D.
• Phone: 821047265594
• Email: bgecs[@]naver.com
• 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 50% effective dose and 95% effective dose of rocuronium according to muscle mass.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anesthesia

Intervention

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))

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	lag time	time from the end of injection of rocuronium until the first depression of the twitch response	ten minutes	No
Primary	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	No
Secondary	onset time	time from the end of injection of rocuronium until the maximal depression of T1 which is result of first twitch	ten minutes	No