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

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

NCT ID: NCT06436768

Condition: Reversal of Neuromuscular Blockade

Conditions: Official terms:
Myasthenia Gravis
Neostigmine

Conditions: Keywords:
neuromuscular blockade
Sugammadex
Neostigmine
Myasthenia gravis
Postoperative Residual Curarization

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Randomized parallel controlled trial

Primary purpose: Treatment

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Masking description: 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

Intervention:

Intervention type: Drug
Intervention name: Sugammadex
Description: 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.
Arm group label: Sugammadex group (S group)

Other name: S group

Intervention type: Drug
Intervention name: Neostigmine
Description: 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.
Arm group label: Neostigmine group (N group)

Other name: N group

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.

Detailed description: Due to neuromuscular transmission and functioning deficits, patients with myasthenia gravis (MG) are at increased risk of postoperative residual curarization (PORC), and may even develop into postoperative myasthenia crisis (PMC), which is a serious complication after thymectomy and increases the risk of death, with an incidence of up to 18.2%. Effective reversal of neuromuscular blockade is crucial to ensure patient safety, reduce the incidence of PORC or PMC and prompt postoperative recovery. Traditionally, neostigmine, an acetylcholinesterase inhibitor, can be employed for neuromuscular blocking agent (NMBA) reversal. However, neostigmine is associated with potential drawbacks, such as delayed recovery and adverse muscarinic side effects. Sugammadex, a selective relaxant binding agent, represents a relatively new alternative for NMBA reversal, specifically designed to encapsulate and inactivate aminosteroid NMBAs. The clinical benefits of sugammadex have been documented in several studies, demonstrating faster reversal of neuromuscular blockade and more predictable recovery profiles compared to neostigmine. However, the use of sugammadex in patients with MG remains an area of limited evidence. To date, to the best of our knowledge, there is a lack of prospective research to elucidate the application value of sugammadex in thymectomy in patients with MG. This study is a prospective randomized controlled trial aimed at exploring the efficacy and safety of sugammadex compared to neostigmine for the reversal of neuromuscular blockade in patients with myasthenia gravis after thoracoscopic thymectomy.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Beijing tongren Hospital, Capital Medical University

Address:
City: Beijing
Zip: 100000
Country: China

Status: Recruiting

Contact:
Last name: Chunhua Hu

Phone: 0086-18310454243
Email: xueliangchunhuayi@163.com

Facility:
Name: The First Affiliated Hospital with Nanjing Medical University

Address:
City: Nanjing
Zip: 210000
Country: China

Status: Recruiting

Contact:
Last name: Shijiang Liu

Phone: 0086-13814001801
Email: liushijiang@njmu.edu.com

Start date: June 1, 2024

Completion date: December 30, 2025

Lead sponsor:
Agency: Beijing Tongren Hospital
Agency class: Other

Collaborator:
Agency: The First Affiliated Hospital with Nanjing Medical University
Agency class: Other

Source: Beijing Tongren Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06436768