NCT05760560

Brief Summary

This study is a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.

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
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

February 26, 2023

Last Update Submit

April 12, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative residual neuromuscular blockade

    TOF ratio \< 0.9

    On the arrival of PACU

Interventions

At the end of surgery, neuromucular blockade will be reversed with 2mg/kg or 4mg/kg sugammadex depending on the depth of neuromuscular blockade.

Eligibility Criteria

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

Patients undergoing elective surgery under general anesthesia will be screened and included in this study.

You may qualify if:

  • Patients undergoing elective surgery under general anesthesia.
  • American Society of Anesthesiologists grade 1, 2, or 3.
  • Aged \>18 years

You may not qualify if:

  • Refusal to participate in the study
  • Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
  • History of neuromuscular disease.
  • History of allergy to neuromuscular blockade
  • Scheduled to transfer to the intensive care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (1)

  • Koo CH, Lee S, Yim S, Bae YK, Park I, Oh AY. Is quantitative neuromuscular monitoring mandatory after administration of the recommended dose of sugammadex? A prospective observational study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101445. doi: 10.1016/j.accpm.2024.101445. Epub 2024 Oct 16.

MeSH Terms

Conditions

Delayed Emergence from Anesthesia

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydrates

Study Officials

  • Chang-Hoon Koo

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang-Hoon Koo

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 26, 2023

First Posted

March 8, 2023

Study Start

March 15, 2023

Primary Completion

August 31, 2023

Study Completion

August 31, 2024

Last Updated

April 14, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations