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

Myasthenia Gravis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05694234
• Other study ID #: 4-2021-0560
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2023
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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. "

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Weakness
• Myasthenia Gravis

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital stay	length of postoperative hospital stay (day)	up to 1 year
Secondary	incidence of postoperative mortality		up to 1 year
Secondary	postoperative complication incidence		up to 1 year
Secondary	postoperative extubation rate in the OR		up to 1 year
Secondary	postoperative reintubation rate in the OR		up to 1 year