Postoperative ComplicationsSECURENCT05788718
An Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety
An observational study of Postoperative Complications and Neuromuscular Blockade, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Complications, Neuromuscular Blockade, Anesthesia
- What is being tested?
- Sugammadex
- How many people
- 6,458 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2023to 8 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
About this study
Official title: 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:
- Prescription pattern of sugammadex
- 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.
- Being tested
- Sugammadex
- Keywords
- sugammadex, rocuronium, vecuronium
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugammadexDrug
As this is a non-interventional study designed to collect data as part of routine clinical practice, the type and dose of neuromuscular blocking agents are all based on the clinician's judgment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-administration rate of sugammadex
The number and ratio of patients re-administered with sugammadex within 24 hours of the initial administration of sugammadex are evaluated.
Measured: baseline~24 hours after administration
Secondary outcomes (13)
Prescription pattern of sugammadex
The ratio of patients is presented for each administered time and dose.
Measured: baseline~24 hours after administration
Incidence rate of postoperative residual curarization (PORC)(TOFr<0.9)
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.
Measured: at 3 and 30 minutes after administration of sugammadex
Incidence rate of postoperative residual curarization (PORC)(TOFr<1.0)
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.
Measured: at 3 and 30 minutes after administration of sugammadex
Analysis of clinical factors affecting sugammadex re-administration
The number and ratio of patients who had these clinical factors are evaluated.
Measured: baseline~24 hours after administration
Incidence rate of respiratory complications related to postoperative residual muscle relaxation after surgery
The number and ratio of patients who had respiratory complications related to postoperative residual muscle relaxation after surgery are evaluated.
Measured: time from the first administration of sugammadex ~ 24 hours after administration
TOFr before sugammadex 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.
Measured: baseline~24 hours after administration
TOFr before extubation
The TOFr (train-of-four ratio) is measured before extubation. The TOFr is expressed as a decimal from 0.0 up to 1.0.
Measured: baseline~24 hours after administration
Time to extubation
The time from the first administration of sugammadex or the last administration of NMBA to the time of extubation is measured in minutes.
Measured: baseline~24 hours after administration
Time surpassed from the expected dismissal time from the recovery room
The time of dismissal from the recovery room is recorded for each patient.
Measured: baseline~24 hours after administration
Ratio of unplanned transfer to the intensive care unit(excluding lung surgery and heart surgery)
The number and ratio of patients who was moved from the recovery room to the intensive care unit unplanned.
Measured: time from the first administration of sugammadex ~ 24 hours after administration
Incidence rate of PONV(postoperative nausea and vomiting)
The number and ratio of patients who experiences PONV(postoperative nausea and vomiting).
Measured: time from the first administration of sugammadex ~ 24 hours after administration
Incidence rate of adverse drug reaction
The number and ratio of patients who experiences adverse drug reactions in which their relationship to sugammadex cannot be ruled out.
Measured: time from the first administration of sugammadex ~ 24 hours after administration
Incidence rate of serious adverse drug reaction
The number and ratio of patients who experiences serious adverse drug reactions in which their relationship to sugammadex cannot be ruled out.
Measured: time from the first administration of sugammadex ~ 24 hours after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start11 Apr 2023
- Primary completion8 May 2025
- Study completion8 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choon-Hak Lim, MD, Principal investigator, Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788718
- Sponsor's protocol ID
- BR-SGD-OS-401
- Acronym
- SECURE
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety in Non-interventional, Real-world Setting
- ClinicalTrials.gov ID
- NCT05788718
- Acronym / sponsor ID
- SECURE / BR-SGD-OS-401
- Keywords
- sugammadex, rocuronium, vecuronium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,458 participants (actual)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 8 May 2025 (actual)
- Study completion
- 8 May 2025 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Prescription pattern of sugammadex
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SugammadexAs this is a non-interventional study designed to collect data as part of routine clinical practice, the type and dose of neuromuscular blocking agents are all based on the clinician's judgment. | Drug | – |
Primary outcome
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.
13 secondary outcomes
Prescription pattern of sugammadex
Time frame: 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
Incidence rate of postoperative residual curarization (PORC)(TOFr<1.0)
Time frame: at 3 and 30 minutes after administration of sugammadex
Analysis of clinical factors affecting sugammadex re-administration
Time frame: 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
TOFr before sugammadex administration
Time frame: baseline~24 hours after administration
TOFr before extubation
Time frame: baseline~24 hours after administration
Time to extubation
Time frame: baseline~24 hours after administration
Time surpassed from the expected dismissal time from the recovery room
Time frame: 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
Incidence rate of PONV(postoperative nausea and vomiting)
Time frame: 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
Incidence rate of serious adverse drug reaction
Time frame: time from the first administration of sugammadex ~ 24 hours after administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Choon-Hak Lim, MD principal investigator
Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Neuromuscular Blockade, run by Boryung Pharmaceutical Co., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-administration rate of sugammadex (time frame: baseline~24 hours after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.