Efficacy and Safety of Sugammadex in Thoracoscopy Thymectomy for Chinese Adults With Myasthenia Gravis

NCT06436768 | Completed

• 2 other identifiers: TRRCKY202 l-009-GZ (2023)-003320.6750.2020-21-10
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

Brief Summary

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

Reversal of Neuromuscular Blockade

Keywords

neuromuscular blockade; Sugammadex; Neostigmine; Myasthenia gravis; Postoperative Residual Curarization

Outcome Measures

Primary Outcomes (1)

• Recovery time

  The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio≥ 0.9

  After operation within 24 hours

Secondary Outcomes (13)

• Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.8

  After operation within 120 minutes

• Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.7.

  After operation within 120 minutes

• Extubation time

  After operation within 60 minutes

• Time to discharge from the operating room

  After operation within 60 minutes

• Time to discharge from recovery room

  After operation within 120 minutes

Study Arms (2)

Sugammadex group (S group)

EXPERIMENTAL

After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered.

Drug: Sugammadex

Neostigmine group (N group)

ACTIVE COMPARATOR

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.

Drug: Neostigmine

Interventions

Sugammadex DRUG

After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered. Dose will be according to participant actual body weight.

Also known as: S group

Sugammadex group (S group)

Neostigmine DRUG

After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine (up to 5 mg maximum dose) plus atropine 0.02 mg/kg (up to 2 mg maximum dose) was administered. Dose will be according to participant actual body weight.

Also known as: N group

Neostigmine group (N group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with MG scheduled for elective thoracoscopic thymectomy
• Aged 18 to 65 years
• American society of Anesthesiologists (ASA) physical status classification system: I - III

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• The First Affiliated Hospital with Nanjing Medical University: collaborator

Study Sites (2)

Beijing tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (20)

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  PMID: 30219643 BACKGROUND

• Sheikh 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.

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• Vymazal 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.

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• van 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 BACKGROUND

• Fernandes 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 BACKGROUND

• No 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.

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• Schaller 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.

  PMID: 27463265 BACKGROUND

• Tsukada S, Shimizu S, Fushimi K. Rocuronium reversed with sugammadex for thymectomy in myasthenia gravis: A retrospective analysis of complications from Japan. Eur J Anaesthesiol. 2021 Aug 1;38(8):850-855. doi: 10.1097/EJA.0000000000001500.

  PMID: 34226417 BACKGROUND

• de Boer HD, Shields MO, Booij LH. Reversal of neuromuscular blockade with sugammadex in patients with myasthenia gravis: a case series of 21 patients and review of the literature. Eur J Anaesthesiol. 2014 Dec;31(12):715-21. doi: 10.1097/EJA.0000000000000153. No abstract available.

  PMID: 25192270 BACKGROUND

• Mouri H, Jo T, Matsui H, Fushimi K, Yasunaga H. Effect of Sugammadex on Postoperative Myasthenic Crisis in Myasthenia Gravis Patients: Propensity Score Analysis of a Japanese Nationwide Database. Anesth Analg. 2020 Feb;130(2):367-373. doi: 10.1213/ANE.0000000000004239.

  PMID: 31124838 BACKGROUND

• Fujimoto M, Terasaki S, Nishi M, Yamamoto T. Response to rocuronium and its determinants in patients with myasthenia gravis: A case-control study. Eur J Anaesthesiol. 2015 Oct;32(10):672-80. doi: 10.1097/EJA.0000000000000257.

  PMID: 26086278 BACKGROUND

• Lai HC, Huang TW, Tseng WC, Wu TS, Wu ZF. Sugammadex and postoperative myasthenic crisis. J Clin Anesth. 2019 Nov;57:63. doi: 10.1016/j.jclinane.2019.02.026. Epub 2019 Mar 12. No abstract available.

  PMID: 30875518 BACKGROUND

• Keating GM. Sugammadex: A Review of Neuromuscular Blockade Reversal. Drugs. 2016 Jul;76(10):1041-52. doi: 10.1007/s40265-016-0604-1.

  PMID: 27324403 BACKGROUND

• Petrun AM, Mekis D, Kamenik M. Successful use of rocuronium and sugammadex in a patient with myasthenia. Eur J Anaesthesiol. 2010 Oct;27(10):917-8. doi: 10.1097/EJA.0b013e3283392593. No abstract available.

  PMID: 20375901 BACKGROUND

• Kiss G, Lacour A, d'Hollander A. Fade of train-of-four ratio despite administration of more than 12 mg kg(-1) sugammadex in a myasthenia gravis patient receiving rocuronium. Br J Anaesth. 2013 May;110(5):854-5. doi: 10.1093/bja/aet098. No abstract available.

  PMID: 23599531 BACKGROUND

• Gurunathan U, Kunju SM, Stanton LML. Use of sugammadex in patients with neuromuscular disorders: a systematic review of case reports. BMC Anesthesiol. 2019 Nov 19;19(1):213. doi: 10.1186/s12871-019-0887-3.

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• Jones RK, Caldwell JE, Brull SJ, Soto RG. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008 Nov;109(5):816-24. doi: 10.1097/ALN.0b013e31818a3fee.

  PMID: 18946293 BACKGROUND

• Blobner M, Eriksson LI, Scholz J, Motsch J, Della Rocca G, Prins ME. Reversal of rocuronium-induced neuromuscular blockade with sugammadex compared with neostigmine during sevoflurane anaesthesia: results of a randomised, controlled trial. Eur J Anaesthesiol. 2010 Oct;27(10):874-81. doi: 10.1097/EJA.0b013e32833d56b7.

  PMID: 20683334 BACKGROUND

• Suy K, Morias K, Cammu G, Hans P, van Duijnhoven WG, Heeringa M, Demeyer I. Effective reversal of moderate rocuronium- or vecuronium-induced neuromuscular block with sugammadex, a selective relaxant binding agent. Anesthesiology. 2007 Feb;106(2):283-8. doi: 10.1097/00000542-200702000-00016.

  PMID: 17264722 BACKGROUND

• Reid JE, Breslin DS, Mirakhur RK, Hayes AH. Neostigmine antagonism of rocuronium block during anesthesia with sevoflurane, isoflurane or propofol. Can J Anaesth. 2001 Apr;48(4):351-5. doi: 10.1007/BF03014962.

  PMID: 11339776 BACKGROUND

MeSH Terms

Conditions

Myasthenia Gravis; Delayed Emergence from Anesthesia

Interventions

Sugammadex; Neostigmine

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Phenylammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Guyan Wang

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The doctors making the follow-up assessment were unaware of the treatment received, and none of the doctors who administered the injections carried out the follow- up evaluations. Thus, both the patients and the assessing doctors were remained unaware of the treatment received throughout the trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel controlled trial

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 31, 2024
• Study Start: June 1, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: April 2, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)