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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT05694234

Collaborator

(none)

265

Enrollment

Location

3.9

Actual Duration (Months)

67.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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. "

Condition or Disease	Intervention/Treatment	Phase
Myasthenia Gravis

Study Design

Study Type:

Observational

Actual Enrollment :

265 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
sugammadex group patients who administered sugammadex
AChEI group patients who administered pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate

Outcome Measures

Primary Outcome Measures

hospital stay [up to 1 year]
length of postoperative hospital stay (day)

Secondary Outcome Measures

incidence of postoperative mortality [up to 1 year]
postoperative complication incidence [up to 1 year]
postoperative extubation rate in the OR [up to 1 year]
postoperative reintubation rate in the OR [up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yonsei University Health System, Severance Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT05694234

Other Study ID Numbers:

4-2021-0560

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Myasthenia Gravis

Muscle Weakness

Study Results

No Results Posted as of Jan 23, 2023