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

Boryung

Status: Completed

Conditions: Postoperative Complications; Neuromuscular Blockade; Anesthesia

Treatments: Drug: Sugammadex

Study type: Observational

Funder types: Industry

Identifiers

NCT05788718

BR-SGD-OS-401

Details and patient eligibility

About

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.

Enrollment: 6,458 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.