Effectiveness of Sugammadex Versus Neostigmine on the Reversal of Rocuronium-induced Neuromuscular Blockade in Patients With Myasthenia Gravis After Thoracoscopic Thymectomy: A Multicenter Randomized Controlled Trial

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Methods: A total of 64 patients with MG undergoing thoracoscopic thymectomy will be randomly divided into two groups: Sugammadex group (S group) and Neostigmine group (N group). The same anesthesia methods will be applied in both groups. Patients of S group will receive a dose of 2.0 mg/kg sugammadex after the last dose of rocuronium, at reappearance of T2. Patients of N group will receive a dose of 50 ug/kg neostigmine after the last dose of rocuronium, at reappearance of T2. The primary endpoint is time from start of administration of sugammadex or neostigmine to recovery of train-of-four stimulation ratio (TOFr) to 0.9. Secondary end points include time from start of administration of sugammadex or neostigmine to recovery of TOFr to 0.8 and 0.7, time to extubation, clinical signs of neuromuscular recovery, hemodynamic changes after muscle relaxation antagonism, adverse effects, time to operating room (OR) discharge, time to post-anesthesia care unit (PACU) discharge, and pulmonary complications within 7 days after the operation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• • Patients with MG scheduled for elective thoracoscopic thymectomy

‣ Aged 18 to 65 years

⁃ American society of Anesthesiologists (ASA) physical status classification system: I - III

Locations
Other Locations
China
Beijing tongren Hospital, Capital Medical University
Beijing
The First Affiliated Hospital with Nanjing Medical University
Nanjing
Time Frame
Start Date: 2024-06-01
Completion Date: 2025-03-05
Participants
Target number of participants: 62
Treatments
Experimental: Sugammadex group (S group)
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered.
Active_comparator: Neostigmine group (N group)
After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine plus atropine 0.02 mg/kg was administered.
Related Therapeutic Areas
Sponsors
Leads: Beijing Tongren Hospital
Collaborators: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov

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