An interventional study of Sugammadex and Neostigmine in Reversal of Neuromuscular Blockade, sponsored by Beijing Tongren Hospital. Completed at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by Beijing Tongren Hospital · Not applicable, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Myasthenia Gravis; 146 are open to participants now.
This study's enrollment of 62 is above the median of 44 across 212 interventional studies indexed under Myasthenia Gravis.
Browse Myasthenia Gravis studies →Beijing Tongren Hospital is the lead sponsor of 154 studies on the registry; 49 are open to participants now.
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Patients with MG scheduled for elective thoracoscopic thymectomy
Exclusion Criteria:
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered.
Drug: Sugammadex
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
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
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
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
Time frame: After operation within 24 hours
Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.8
Muscle relaxation monitoring was performed with an accelero-myography (AMG) neuromuscular monitor by assessment of the TOF responses of adductor pollicis muscle to ulnar nerve stimulation every 15 seconds. T1 and T4 refer to the amplitudes of the first and fourth twitches, respectively, after TOF nerve stimulation. The TOFr, that is T4/T1 Ratio (expressed as a decimal of up to 1.0) represents the extent of recovery from neuromuscular blockade (NMB). A faster time to TOFr 0.8 indicates a faster recovery from NMB.
Time frame: After operation within 120 minutes
Time from start of administration of sugammadex or neostigmine to the train-of-four stimulation ratio (TOFr) 0.7.
Muscle relaxation monitoring was performed with an accelero-myography (AMG) neuromuscular monitor by assessment of the TOF responses of adductor pollicis muscle to ulnar nerve stimulation every 15 seconds. T1 and T4 refer to the amplitudes of the first and fourth twitches, respectively, after TOF nerve stimulation. The TOFr, that is T4/T1 Ratio (expressed as a decimal of up to 1.0) represents the extent of recovery from neuromuscular blockade (NMB). A faster time to TOFr 0.7 indicates a faster recovery from NMB.
Time frame: After operation within 120 minutes
Extubation time
The time period between administering a reversal agent to extubation
Time frame: After operation within 60 minutes
Time to discharge from the operating room
The time period between administering a reversal agent to operating room discharge
Time frame: After operation within 60 minutes
Time to discharge from recovery room
The time period between entering the recovery room amd discharge from recovery room
Time frame: After operation within 120 minutes
Incidence of postoperative residual neuromuscular blockade (rNMB)
Incidence of postoperative residual neuromuscular blockade (rNMB) (defined as a train-of-four ratio, TOFR \<0.9) measured 30 min after administration of the reversal agent.
Time frame: After operation within 24 hours
The incidence of adverse effects
Unit: %; This value is a percentage. Any adverse effects in the operating room or in PACU include procedural pain, nausea, vomiting, dizziness, pruritus, reintubation, incision site complication, postprocedural nausea, vomiting, flatulence, procedural complication, insomnia, muscular weakness, headache, pharyngolaryngeal pain.
Time frame: Within 48 hours after operation
Number of patients who need rescue medication
After extubation to prior to discharge from the recovery room, record the number of patients who need rescue medication because of clinical signs of residual paralysis (i.e. if a patient complain about muscle weakness, difficulty breathing, or oxygen desaturation ≤ 95%)
Time frame: After operation within 24 hours
The incidence of mean arterial blood pressure fluctuations ≥20%
The proportion of patients in this group who experience mean arterial blood pressure fluctuation ≥ 20% within 30 minutes after administration of antagonists compared with before administration of antagonists
Time frame: After operation within 24 hours
The incidence of heart rate fluctuations ≥20%
The proportion of patients in this group who experience heart rate fluctuation ≥ 20% within 30 minutes after administration of antagonists compared with before administration of antagonists
Time frame: After operation within 24 hours
The incidence of postoperative pulmonary complications
Unit: %; This value is a percentage. Postoperative pulmonary complications include pneumonia; aspiration pneumonitis; atelectasis; respiratory failure; bronchospasm; pulmonary congestion; pleural effusion; pneumothorax.
Time frame: Within the first 7 days after surgery
Unplanned ICU hospitalization rate
Unit: %; This value is a percentage.
Time frame: 1 months after operation
Hypoxemic events
Blood oxygenation values will be measured using pulse oximetry from the time of PACU admission until discharge from the PACU
Time frame: participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days
Plan to share: No
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Beijing Tongren Hospital