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

Anesthesia Clinical Trial

— SECURE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788718
• Other study ID #: BR-SGD-OS-401
• Status: Recruiting
• Start date: April 11, 2023
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: MyungSook Hong
• Phone: +8227088238
• Email: mshong[@]boryung.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: August 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Neuromuscular Blockade
• Postoperative Complications

Intervention

Drug:
• Sugammadex
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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul	Seongbuk-gu

Sponsors (1)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prescription pattern of sugammadex	The ratio of patients is presented for each administered time and dose.	baseline~24 hours after administration
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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