NCT04688268

Brief Summary

Find out the deciding factor(total body weight, corrected body weight, ideal body weight, fat-free mass, body mass index, skeletal muscle mass, body fat) of neuromuscular blocker dose for deep neuromuscular blockade.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

January 10, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

December 30, 2020

Status Verified

December 1, 2020

Enrollment Period

7 months

First QC Date

December 23, 2020

Last Update Submit

December 28, 2020

Conditions

Keywords

laparoscopic surgerydeep neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • the highest correlation coefficient

    the relationship of rocuronium for deep neuromuscular blockade and 8 factors (corrected body weight, ideal body weight, lean body weight, fat-free mass, body mass index, skeletal muscle mass, body fat)

    preoperative 1 days to postoperative 1 days

Secondary Outcomes (3)

  • onset time of rocuronium

    preoperative 1 days to postoperative 1 days

  • Time to deep neuromuscular blockade

    preoperative 1 days to postoperative 1 days

  • Recovery time

    preoperative 1 days to postoperative 1 days

Study Arms (1)

deep neuromuscular blockade

patients who underwent surgery with deep neuromuscular blockade

Drug: deep neuromuscular blockade

Interventions

Train of Four=0/4, Post tetanic count 1-2

deep neuromuscular blockade

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia.

You may qualify if:

  • patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo laparoscopic surgery for at least 2 hours under general anesthesia

You may not qualify if:

  • kidney disease (GFR\<60)
  • allergy to study drugs
  • decline participation
  • side effect of propofol and remifentanil
  • when anesthesia does not maintain the level of alertness (BIS) below 60 even when the anesthetic dose is increased, or when hemodynamic instability such as bradycardia and hypotension appears

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Choi YJ, Hee Kim Y, Bae GE, Yu JH, Yoon SZ, Kang HW, Lee KS, Kim JH, Lee YS. Relationship between the muscle relaxation effect and body muscle mass measured using bioelectrical impedance analysis: A nonrandomized controlled trial. J Int Med Res. 2019 Apr;47(4):1521-1532. doi: 10.1177/0300060518822197. Epub 2019 Feb 5.

    PMID: 30719949BACKGROUND

Central Study Contacts

Ah-young Oh, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 29, 2020

Study Start

January 10, 2021

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

December 30, 2020

Record last verified: 2020-12