Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Reversal of Neuromuscular Blockade | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neostigmine | Drug | — | UNRESOLVED |
| Sugammadex | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sugammadex group (S group)
- description
- After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered.
- interventionNames
- Drug: Sugammadex
- type
- ACTIVE_COMPARATOR
- label
- Neostigmine group (N group)
- description
- 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.
- interventionNames
- Drug: Neostigmine
Primary outcomes (1)
- measure
- Recovery time
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * • Patients with MG scheduled for elective thoracoscopic thymectomy * Aged 18 to 65 years * American society of Anesthesiologists (ASA) physical status classification system: I - III Exclusion Criteria: * Inability to obtain written informed consent * With severe renal or hepatic dysfunction * A plan to return to ICU with intubation postoperation * A family history of malignant hyperthermia * Suspected difficult airway * Allergy to medications involved in the study * A contraindication for neostigmine or sugammadex administration * The patient's arm is not available for neuromuscular monitoring * Patients receiving medication known to interfere with NMBAs (e.g., anticonvulsants, antibiotics, magnesium salts) * Pregnant or lactating patients
References
Publications (20)
- RESULTCata JP, Lasala JD, Williams W, Mena GE. Myasthenia Gravis and Thymoma Surgery: A Clinical Update for the Cardiothoracic Anesthesiologist. J Cardiothorac Vasc Anesth. 2019 Sep;33(9):2537-2545. doi: 10.1053/j.jvca.2018.07.036. Epub 2018 Jul 29. PMID 30219643
- RESULTSheikh S, Alvi U, Soliven B, Rezania K. Drugs That Induce or Cause Deterioration of Myasthenia Gravis: An Update. J Clin Med. 2021 Apr 6;10(7):1537. doi: 10.3390/jcm10071537. PMID 33917535
- RESULTVymazal T, Krecmerova M, Bicek V, Lischke R. Feasibility of full and rapid neuromuscular blockade recovery with sugammadex in myasthenia gravis patients undergoing surgery - a series of 117 cases. Ther Clin Risk Manag. 2015 Oct 15;11:1593-6. doi: 10.2147/TCRM.S93009. eCollection 2015. PMID 26508869
- RESULTvan den Bersselaar LR, Gubbels M, Riazi S, Heytens L, Jungbluth H, Voermans NC, Snoeck MMJ. Mapping the current evidence on the anesthetic management of adult patients with neuromuscular disorders-a scoping review. Can J Anaesth. 2022 Jun;69(6):756-773. doi: 10.1007/s12630-022-02230-3. Epub 2022 Mar 23. PMID 35322378
- RESULTFernandes HDS, Ximenes JLS, Nunes DI, Ashmawi HA, Vieira JE. Failure of reversion of neuromuscular block with sugammadex in patient with myasthenia gravis: case report and brief review of literature. BMC Anesthesiol. 2019 Aug 17;19(1):160. doi: 10.1186/s12871-019-0829-0. PMID 31421671
- RESULTNo HJ, Yoo YC, Oh YJ, Lee HS, Jeon S, Kweon KH, Kim NY. Comparison between Sugammadex and Neostigmine after Video-Assisted Thoracoscopic Surgery-Thymectomy in Patients with Myasthenia Gravis: A Single-Center Retrospective Exploratory Analysis. J Pers Med. 2023 Sep 15;13(9):1380. doi: 10.3390/jpm13091380. PMID 37763148
- RESULTSchaller SJ, Lewald H. Clinical pharmacology and efficacy of sugammadex in the reversal of neuromuscular blockade. Expert Opin Drug Metab Toxicol. 2016 Sep;12(9):1097-108. doi: 10.1080/17425255.2016.1215426. Epub 2016 Aug 3.