An Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety (SECURE)

April 8, 2026 updated by: Boryung Pharmaceutical Co., Ltd

A Multicenter, Prospective, Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety in Non-interventional, Real-world Setting

The purpose of this observational study is to evaluate patients who are planning to administer sugammadex after rocuronium or vecuronium is used.

The main questions it aims to answer are:

  1. Prescription pattern of sugammadex
  2. Effectiveness and safety of sugammadex

Since this study is observational, only data generated under daily treatment are to be collected, and no additional tests or drug administration is conducted for the study. The patients are observed from baseline to 24 hours after the initial administration of sugammadex.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6458

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • South Korea
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, South Korea, 02841
        • Korea University Anam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are planning to undergo surgery using rocuronium or vecuronium for the neuromuscular blockade and planned to receive sugammadex for the antagonist.

Description

Inclusion Criteria:

  • Male or female adults aged 19 or older
  • Is to undergo elective surgery under general anesthesia
  • Is planned to use rocuronium or vecuronium as an NMBA
  • Is planned for extubation before/after being moved to the recovery room
  • ASA physical status I - III
  • Patients who have signed the informed consent after receiving information about the purpose and method of this study

Exclusion Criteria:

  • Has myasthenia gravis or Eaton-Lambert myasthenic syndrome
  • Has hypersensitivity to ingredients of sugammadex, rocuronium, or vecuronium
  • Has received an investigational product within 12 weeks from the study enrollment or has plans to participate in another clinical trial during the participation of this study.
  • Other subjects who are considered inappropriate to participate in this study by the judgment of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Re-administration rate of sugammadex
Time Frame: baseline~24 hours after administration
The number and ratio of patients re-administered with sugammadex within 24 hours of the initial administration of sugammadex are evaluated.
baseline~24 hours after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prescription pattern of sugammadex
Time Frame: baseline~24 hours after administration
The ratio of patients is presented for each administered time and dose.
baseline~24 hours after administration
Incidence rate of postoperative residual curarization (PORC)(TOFr<0.9)
Time Frame: at 3 and 30 minutes after administration of sugammadex
The TOFr (train-of-four ratio) is measured at 3 and 30 minutes after administration of sugammadex. The number and ratio of patients with a TOFr <0.9 are defined as PORC(TOFr<0.9). The TOFr is expressed as a decimal from 0.0 up to 1.0.
at 3 and 30 minutes after administration of sugammadex
Incidence rate of postoperative residual curarization (PORC)(TOFr<1.0)
Time Frame: at 3 and 30 minutes after administration of sugammadex
The TOFr (train-of-four ratio) is measured at 3 and 30 minutes after administration of sugammadex. The number and ratio of patients with a TOFr <1.0 are defined as PORC(TOFr<1.0). The TOFr is expressed as a decimal from 0.0 up to 1.0.
at 3 and 30 minutes after administration of sugammadex
Analysis of clinical factors affecting sugammadex re-administration
Time Frame: baseline~24 hours after administration
The number and ratio of patients who had these clinical factors are evaluated.
baseline~24 hours after administration
Incidence rate of respiratory complications related to postoperative residual muscle relaxation after surgery
Time Frame: time from the first administration of sugammadex ~ 24 hours after administration
The number and ratio of patients who had respiratory complications related to postoperative residual muscle relaxation after surgery are evaluated.
time from the first administration of sugammadex ~ 24 hours after administration
TOFr before sugammadex administration
Time Frame: baseline~24 hours after administration
The TOFr (train-of-four ratio) is measured before each administration of sugammadex. The TOFr is expressed as a decimal from 0.0 up to 1.0.
baseline~24 hours after administration
TOFr before extubation
Time Frame: baseline~24 hours after administration
The TOFr (train-of-four ratio) is measured before extubation. The TOFr is expressed as a decimal from 0.0 up to 1.0.
baseline~24 hours after administration
Time to extubation
Time Frame: baseline~24 hours after administration
The time from the first administration of sugammadex or the last administration of NMBA to the time of extubation is measured in minutes.
baseline~24 hours after administration
Time surpassed from the expected dismissal time from the recovery room
Time Frame: baseline~24 hours after administration
The time of dismissal from the recovery room is recorded for each patient.
baseline~24 hours after administration
Ratio of unplanned transfer to the intensive care unit(excluding lung surgery and heart surgery)
Time Frame: time from the first administration of sugammadex ~ 24 hours after administration
The number and ratio of patients who was moved from the recovery room to the intensive care unit unplanned.
time from the first administration of sugammadex ~ 24 hours after administration
Incidence rate of PONV(postoperative nausea and vomiting)
Time Frame: time from the first administration of sugammadex ~ 24 hours after administration
The number and ratio of patients who experiences PONV(postoperative nausea and vomiting).
time from the first administration of sugammadex ~ 24 hours after administration
Incidence rate of adverse drug reaction
Time Frame: time from the first administration of sugammadex ~ 24 hours after administration
The number and ratio of patients who experiences adverse drug reactions in which their relationship to sugammadex cannot be ruled out.
time from the first administration of sugammadex ~ 24 hours after administration
Incidence rate of serious adverse drug reaction
Time Frame: time from the first administration of sugammadex ~ 24 hours after administration
The number and ratio of patients who experiences serious adverse drug reactions in which their relationship to sugammadex cannot be ruled out.
time from the first administration of sugammadex ~ 24 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boryung Pharmaceutical Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Choon-Hak Lim, MD, Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BR-SGD-OS-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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