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

NCT ID: NCT05788718

Last Updated: 2025-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6458 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-11

Study Completion Date

2025-05-08

Brief Summary

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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

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Conditions

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Postoperative Complications Neuromuscular Blockade Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boryung Pharmaceutical Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Choon-Hak Lim, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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BR-SGD-OS-401

Identifier Type: -

Identifier Source: org_study_id

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