Clinical trial NCT06436768: Efficacy and Safety of Sugammadex in Thoracoscopy Thymectomy for Chinese Adults With Myasthenia Gravis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reversal of Neuromuscular Blockade
Keywords: neuromuscular blockade
Sugammadex
Neostigmine
Myasthenia gravis
Postoperative Residual Curarization
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
First posted: 2024-05-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel controlled trial
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Recovery time
timeFrame: After operation within 24 hours
Secondary outcomes:
measure: Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.8
timeFrame: After operation within 120 minutes
measure: Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.7.
timeFrame: After operation within 120 minutes
measure: Extubation time
timeFrame: After operation within 60 minutes
measure: Time to discharge from the operating room
timeFrame: After operation within 60 minutes
measure: Time to discharge from recovery room
timeFrame: After operation within 120 minutes
measure: Incidence of postoperative residual neuromuscular blockade (rNMB)
timeFrame: After operation within 24 hours
measure: The incidence of adverse effects
timeFrame: Within 48 hours after operation
measure: Number of patients who need rescue medication
timeFrame: After operation within 24 hours
measure: The incidence of mean arterial blood pressure fluctuations ≥20%
timeFrame: After operation within 24 hours
measure: The incidence of heart rate fluctuations ≥20%
timeFrame: After operation within 24 hours
measure: The incidence of postoperative pulmonary complications
timeFrame: Within the first 7 days after surgery
measure: Unplanned ICU hospitalization rate
timeFrame: 1 months after operation
measure: Hypoxemic events
timeFrame: participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing tongren Hospital, Capital Medical University
state: Beijing
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Beijing Tongren Hospital
name: Guyan Wang
role: STUDY_DIRECTOR
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