Myasthenia GravisNCT05694234
Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
An observational study of Myasthenia Gravis, run by Yonsei University at 1 site in South Korea.
Trial summary
"Several case reports have described the use of rocuronium and sugammadex in patients with myasthenia gravis (MG). However, reports regarding the effects of sugammadex compared with that of acetylcholinesterase inhibitors (AChEIs) on perioperative outcomes of video-assisted thoracoscopic surgery (VATS)-thymectomy in… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myasthenia Gravis
- How many people
- 265 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with myasthenia gravis who underwent video-assisted thoracoscopic thymectomy
Who may be able to join
- patients underwent VATS-thymectomy between November 2007 and December 2020
Who cannot join
- Patients who was not diagnosed with myasthenia gravis
- Age ≤ 18
- Patients for which no reversal agent was used
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
"Several case reports have described the use of rocuronium and sugammadex in patients with myasthenia gravis (MG). However, reports regarding the effects of sugammadex compared with that of acetylcholinesterase inhibitors (AChEIs) on perioperative outcomes of video-assisted thoracoscopic surgery (VATS)-thymectomy in patients with MG are still lacking. Thus, the investigators will investigate the effects of sugammadex compared to AChEIs on the postoperative recovery in patients with MG who underwent VATS-thymectomy.
This retrospective study include patients with MG, aged> 18 years who received sugammadex or pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate after VATS-thymectomy between November 2007 and December 2020. Inverse Probability of Treatment Weighting (IPTW) adjustment will be performed to balance the baseline characteristics between the two groups. The primary outcome is the length of postoperative hospital stay, and the secondary outcomes are the incidence of postoperative mortality and postoperative complications, as well as postoperative extubation and reintubation rates in the operating room after VATS-thymectomy; the outcomes are compared between the two groups. "
- Conditions
- Myasthenia Gravis
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sugammadex group | patients who administered sugammadex | |
| AChEI group | patients who administered pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital stay
length of postoperative hospital stay (day)
Measured: up to 1 year
Secondary outcomes (4)
incidence of postoperative mortality
Measured: up to 1 year
postoperative complication incidence
Measured: up to 1 year
postoperative extubation rate in the OR
Measured: up to 1 year
postoperative reintubation rate in the OR
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start1 Sep 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Na Young Kim, Principal investigator, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694234
- Sponsor's protocol ID
- 4-2021-0560
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
- ClinicalTrials.gov ID
- NCT05694234
- Acronym / sponsor ID
- 4-2021-0560
- Conditions
- Myasthenia Gravis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Several case reports have described the use of rocuronium and sugammadex in patients with myasthenia gravis (MG). However, reports regarding the effects of sugammadex compared with that of acetylcholinesterase inhibitors (AChEIs) on perioperative outcomes of video-assisted thoracoscopic surgery (VATS)-thymectomy in patients with MG are still lacking. Thus, the investigators will investigate the effects of sugammadex compared to AChEIs on the postoperative recovery in patients with MG who underwent VATS-thymectomy.
This retrospective study include patients with MG, aged> 18 years who received sugammadex or pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate after VATS-thymectomy between November 2007 and December 2020. Inverse Probability of Treatment Weighting (IPTW) adjustment will be performed to balance the baseline characteristics between the two groups. The primary outcome is the length of postoperative hospital stay, and the secondary outcomes are the incidence of postoperative mortality and postoperative complications, as well as postoperative extubation and reintubation rates in the operating room after VATS-thymectomy; the outcomes are compared between the two groups. "
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugammadex group | – | –patients who administered sugammadex |
| AChEI group | – | –patients who administered pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myasthenia gravis who underwent video-assisted thoracoscopic thymectomy
Key inclusion criteria (1 listed)
- patients underwent VATS-thymectomy between November 2007 and December 2020
Key exclusion criteria (3 listed)
- Patients who was not diagnosed with myasthenia gravis
- Age ≤ 18
- Patients for which no reversal agent was used
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hospital stay
Time frame: up to 1 year
length of postoperative hospital stay (day)
4 secondary outcomes
incidence of postoperative mortality
Time frame: up to 1 year
postoperative complication incidence
Time frame: up to 1 year
postoperative extubation rate in the OR
Time frame: up to 1 year
postoperative reintubation rate in the OR
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Na Young Kim principal investigator
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital stay (time frame: up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.