NCT06436768Completed
Efficacy and Safety of Sugammadex in Thoracoscopy Thymectomy for Chinese Adults With Myasthenia Gravis
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
Source: ClinicalTrials.gov · Last updated 2 Apr 2025
Brief summary (registry, in English)
The purpose of this study was to demonstrate in patients with myasthenia gravis (MG) undergoing thoracoscopic thymectomy faster recovery from a moderate neuromuscular block induced by rocuronium after reversal at reappearance of T2 by 2.0 mg/kg sugammadex compared to 50 ug/kg neostigmine. 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 14 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- 5 Mar 2025
- Lead sponsor
- Beijing Tongren Hospital
- Diseases
- Myasthenia gravis
- NCT number
- NCT06436768
What you commit to
- Study type: Interventional
- Participants enrolled: 62
- From 1 Jun 2024 to the primary completion date, 5 Mar 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- A family history of malignant hyperthermia
- Allergy to medications involved in the study
Lab values
- Patients receiving medication known to interfere with NMBAs (e.g., anticonvulsants, antibiotics, magnesium salts)
Other
- Inability to obtain written informed consent
- With severe renal or hepatic dysfunction
- A plan to return to ICU with intubation postoperation
- Suspected difficult airway
- A contraindication for neostigmine or sugammadex administration
- The patient's arm is not available for neuromuscular monitoring
- Pregnant or lactating patients
Who the study is looking for
- • Patients with MG scheduled for elective thoracoscopic thymectomy
- Aged 18 to 65 years
- American society of Anesthesiologists (ASA) physical status classification system: I - III
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.