Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study

January 20, 2023 updated by: Yonsei University

"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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

265

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with myasthenia gravis who underwent video-assisted thoracoscopic thymectomy

Description

Inclusion Criteria:

  • patients underwent VATS-thymectomy between November 2007 and December 2020

Exclusion Criteria:

  • Patients who was not diagnosed with myasthenia gravis
  • Age ≤ 18
  • Patients for which no reversal agent was used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
sugammadex group
patients who administered sugammadex
AChEI group
patients who administered pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hospital stay
Time Frame: up to 1 year
length of postoperative hospital stay (day)
up to 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of postoperative mortality
Time Frame: up to 1 year
up to 1 year
postoperative complication incidence
Time Frame: up to 1 year
up to 1 year
postoperative extubation rate in the OR
Time Frame: up to 1 year
up to 1 year
postoperative reintubation rate in the OR
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Na Young Kim, Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2021-0560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

3years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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