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

NCT05788718 | Completed

• 1 other identifier: BR-SGD-OS-401
• Study Type: observational
• Target: 6,458
• Locations: 1 country
• Sites: 1

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. 1.Prescription pattern of sugammadex
2. 2.Effectiveness and safety of sugammadex

Conditions

Postoperative Complications; Neuromuscular Blockade; Anesthesia

Keywords

sugammadex; rocuronium; vecuronium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Prescription pattern of sugammadex

  baseline~24 hours after administration

• Incidence rate of postoperative residual curarization (PORC)(TOFr<0.9)

  at 3 and 30 minutes after administration of sugammadex

• Incidence rate of postoperative residual curarization (PORC)(TOFr<1.0)

  at 3 and 30 minutes after administration of sugammadex

• Analysis of clinical factors affecting sugammadex re-administration

  baseline~24 hours after administration

• Incidence rate of respiratory complications related to postoperative residual muscle relaxation after surgery

  time from the first administration of sugammadex ~ 24 hours after administration

Interventions

Sugammadex DRUG

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boryung Pharmaceutical Co., Ltd: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Choon-Hak Lim, MD

  Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 29, 2023
• Study Start: April 11, 2023
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)