Clinical trial NCT05788718: An Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety
Official title: A Multicenter, Prospective, Observational Study to Analyze the Prescription Pattern of Sugammadex and Its Effectiveness and Safety in Non-interventional, Real-world Setting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Neuromuscular Blockade
Anesthesia
Keywords: sugammadex
rocuronium
vecuronium
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-29
Enrollment: 7000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Re-administration rate of sugammadex
timeFrame: baseline~24 hours after administration
Secondary outcomes:
measure: Prescription pattern of sugammadex
timeFrame: baseline~24 hours after administration
measure: Incidence rate of postoperative residual curarization (PORC)(TOFr<0.9)
timeFrame: at 3 and 30 minutes after administration of sugammadex
measure: Incidence rate of postoperative residual curarization (PORC)(TOFr<1.0)
timeFrame: at 3 and 30 minutes after administration of sugammadex
measure: Analysis of clinical factors affecting sugammadex re-administration
timeFrame: baseline~24 hours after administration
measure: Incidence rate of respiratory complications related to postoperative residual muscle relaxation after surgery
timeFrame: time from the first administration of sugammadex ~ 24 hours after administration
measure: TOFr before sugammadex administration
timeFrame: baseline~24 hours after administration
measure: TOFr before extubation
timeFrame: baseline~24 hours after administration
measure: Time to extubation
timeFrame: baseline~24 hours after administration
measure: Time surpassed from the expected dismissal time from the recovery room
timeFrame: baseline~24 hours after administration
measure: Ratio of unplanned transfer to the intensive care unit(excluding lung surgery and heart surgery)
timeFrame: time from the first administration of sugammadex ~ 24 hours after administration
measure: Incidence rate of PONV(postoperative nausea and vomiting)
timeFrame: time from the first administration of sugammadex ~ 24 hours after administration
measure: Incidence rate of adverse drug reaction
timeFrame: time from the first administration of sugammadex ~ 24 hours after administration
measure: Incidence rate of serious adverse drug reaction
timeFrame: time from the first administration of sugammadex ~ 24 hours after administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-gu
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Korea University Medical Center, Seoul, Korea.
name: Choon-Hak Lim, MD
role: PRINCIPAL_INVESTIGATOR
References: