NCT05515835

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 22, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

August 22, 2022

Last Update Submit

January 2, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • time to loss of TOF

    up to 5 minutes after rocuronium administration during induction of anesthesia

Study Arms (1)

rocuronium

The patient will be given 50mg of rocuronium intravenously for induction.

Device: body composition analysis

Interventions

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

rocuronium

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with ASA class I-II undergoing total intravenous general anesthesia

You may qualify if:

  • Adult patients with ASA class I-II undergoing total intravenous general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center, Sungkyunkwan University, School of Medicine

Seoul, 06351, South Korea

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 25, 2022

Study Start

September 5, 2022

Primary Completion

December 30, 2022

Study Completion

March 1, 2023

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations