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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Recovery time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients with MG scheduled for elective thoracoscopic thymectomy
- •Aged 18 to 65 years
- •American society of Anesthesiologists (ASA) physical status classification system: I - III
排除标准
- •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
研究组 & 干预措施
Sugammadex group (S group)
After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered.
干预措施: Sugammadex (Drug)
Neostigmine group (N group)
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.
干预措施: Neostigmine (Drug)
结局指标
主要结局
Recovery time
时间窗: After operation within 24 hours
The comparison of the recovery periods between groups when the start of administering reversal agent to the recovery of TOF ratio≥ 0.9
次要结局
- 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)
- The incidence of mean arterial blood pressure fluctuations ≥20%(After operation within 24 hours)
- The incidence of heart rate fluctuations ≥20%(After operation within 24 hours)
- The incidence of postoperative pulmonary complications(Within the first 7 days after surgery)
- Hypoxemic events(participants will be followed for the duration of the PACU stay, an expected average of 2 hours, up to 7 days)
- Incidence of postoperative residual neuromuscular blockade (rNMB)(After operation within 24 hours)
- Number of patients who need rescue medication(After operation within 24 hours)
- Unplanned ICU hospitalization rate(1 months after operation)
- The incidence of adverse effects(Within 48 hours after operation)