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

Recruiting

• Conditions: Postoperative Complications; Neuromuscular Blockade; Anesthesia

• Registration Number: NCT05788718
• Lead Sponsor: Boryung Pharmaceutical Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-29
• Study Start: 2023-04-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Re-administration rate of sugammadex	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.

Secondary Outcome Measures

Name	Time	Method
Prescription pattern of sugammadex	baseline~24 hours after administration	The ratio of patients is presented for each administered time and dose.
Incidence rate of postoperative residual curarization (PORC)(TOFr<0.9)	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.
Incidence rate of postoperative residual curarization (PORC)(TOFr<1.0)	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.
Analysis of clinical factors affecting sugammadex re-administration	baseline~24 hours after administration	The number and ratio of patients who had these clinical factors are evaluated.
Incidence rate of respiratory complications related to postoperative residual muscle relaxation after surgery	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.
TOFr before sugammadex administration	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.
TOFr before extubation	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.
Time surpassed from the expected dismissal time from the recovery room	baseline~24 hours after administration	The time of dismissal from the recovery room is recorded for each patient.
Ratio of unplanned transfer to the intensive care unit(excluding lung surgery and heart surgery)	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.
Incidence rate of adverse drug reaction	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.
Incidence rate of serious adverse drug reaction	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 to extubation	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.
Incidence rate of PONV(postoperative nausea and vomiting)	time from the first administration of sugammadex ~ 24 hours after administration	The number and ratio of patients who experiences PONV(postoperative nausea and vomiting).

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Seongbuk-gu, Korea, Republic of