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NCT05515835 Clinical Trial

Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.

Body Composition Clinical Trial

Official title:
Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05515835
Other study ID # SMC 2022-07-160
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date September 5, 2022
Est. completion date March 2023

Study information
Verified date January 2023
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The induction dose of rocuronium is typically decided based on the patient's body weight, but the effect duration of rocuronium is variable. Some studies suggest that body composition analysis data, such as skeletal muscle mass or total body water, may correlate better with the duration time of rocuronium. Therefore, we plan to analyse body composition in patients undergoing total intravenous general anesthesia, give the patients a fixed dose (50mg) of rocuronium, and check the correlation between duration time of rocuronium and body composition analysis data.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 88
Est. completion date March 2023
Est. primary completion date December 30, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - Adult patients with ASA class I-II undergoing total intravenous general anesthesia Exclusion Criteria: - too overweight (over 111.11kg, which corresponds to less than 0.45mg/kg of induction dose of rocuronium) - too underweight (under 41.67kg, which corresponds to more than 1.2mg/kg of induction dose of rocuronium) - pregnancy - prediagnosed muscle or nerve related disease - unsuitable for body composition analysis using bioelectrical impedance method - unsuitable for neuromuscular block monitoring

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• body composition analysis
Patients will undergo body composition analysis using bioelectical impedance method before anesthesia.

Locations
Country Name City State
Korea, Republic of Samsung Medical Center, Sungkyunkwan University, School of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary time to TOF1 correlation between the time from induction to recovery of 1st TOF twitch and age, sex, ASA class, body weight, and body composition analysis data up to 1 hour after rocuronium administration during induction of anesthesia
Primary time to TOF4 correlation between the time from induction to recovery of 4th TOF twitch and age, sex, ASA class, body weight, and body composition analysis data up to 1.5 hour after rocuronium administration during induction of anesthesia
Secondary time to loss of TOF correlation between the time from injection of rocuronium to complete loss of TOF twitch and age, sex, ASA class, body weight, and body composition analysis data up to 5 minutes after rocuronium administration during induction of anesthesia
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