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

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: Completed
• Conditions: Postoperative Complications; Anesthesia; Neuromuscular Blockade
• Intervention / Treatment: Drug: Sugammadex

• Study Type: Observational
• Enrollment (Actual): 6458

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline~24 hours after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription pattern of sugammadex	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)	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)	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	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	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	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	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	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	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)	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)	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	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	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

• Sponsor: Boryung Pharmaceutical Co., Ltd
• Investigators: Principal Investigator: Choon-Hak Lim, MD, Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2023
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: February 9, 2023
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: rocuronium; sugammadex; vecuronium
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Carbohydrates; Polycyclic Compounds; Polysaccharides; Macrocyclic Compounds; gamma-Cyclodextrins; Cyclodextrins; Dextrins; Starch; Glucans; Sugammadex
• Other Study ID 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