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Completed

NCT Number: NCT05788718

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

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.

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Key information

Conditions

Postoperative Complications Anesthesia Neuromuscular Blockade Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Re-administration rate of sugammadex

    Time frame: 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 outcomes

  1. Prescription pattern of sugammadex

    Time frame: baseline~24 hours after administration

    The ratio of patients is presented for each administered time and dose.

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

    Time frame: 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.

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

    Time frame: 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.

  4. Analysis of clinical factors affecting sugammadex re-administration

    Time frame: baseline~24 hours after administration

    The number and ratio of patients who had these clinical factors are evaluated.

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

    Time frame: 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.

  6. TOFr before sugammadex administration

    Time frame: 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.

  7. TOFr before extubation

    Time frame: 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.

  8. Time to extubation

    Time frame: 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.

  9. Time surpassed from the expected dismissal time from the recovery room

    Time frame: baseline~24 hours after administration

    The time of dismissal from the recovery room is recorded for each patient.

  10. Ratio of unplanned transfer to the intensive care unit(excluding lung surgery and heart surgery)

    Time frame: 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.

  11. Incidence rate of PONV(postoperative nausea and vomiting)

    Time frame: time from the first administration of sugammadex ~ 24 hours after administration

    The number and ratio of patients who experiences PONV(postoperative nausea and vomiting).

  12. Incidence rate of adverse drug reaction

    Time frame: 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.

  13. Incidence rate of serious adverse drug reaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

A Multicenter, Prospective, Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety in Non-interventional, Real-world Setting

Acronym: SECURE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 29, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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