NCT04709406

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 in bariatric surgery.

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

Study Start

First participant enrolled

January 1, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

January 12, 2021

Last Update Submit

January 12, 2021

Conditions

Keywords

bariatric surgerydeep neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

  • the highest correlation coefficient

    the relationship of rocuronium for deep neuromuscular blockade in bariatric surgery 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)

obese patients

obese patients underwent bariatric surgery

Drug: deep neuromuscular blockade in bariatric surgery

Interventions

obese patients who underwent bariatric surgery

obese patients

Eligibility Criteria

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

obese patients who scheduled bariatric surgery

You may qualify if:

  • Patients aged 20-80 and American Society of Anesthesiology Physical Grade (ASA) I-II, who undergo bariatric surgery

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

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Central Study Contacts

Ah-young Oh, professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

January 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

January 14, 2021

Record last verified: 2021-01