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

Study Overview
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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: Prescription pattern of sugammadex 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.

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

Conditions
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Postoperative Complications, Neuromuscular Blockade, Anesthesia

Intervention / Treatment
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* Drug: Sugammadex


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription pattern of sugammadex | The ratio of patients is presented for each administered time and dose. | baseline 24 hours after administration | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sugammadex, rocuronium, vecuronium