Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06436768
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-14
Brief Title:
Efficacy and Safety of Sugammadex in Thoracoscopy Thymectomy for Chinese Adults With Myasthenia Gravis
Sponsor:
Beijing Tongren Hospital
Organization:
Beijing Tongren Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20 mgkg sugammadex compared to 50 ugkg 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 20 mgkg sugammadex after the last dose of rocuronium at reappearance of T2 Patients of N group will receive a dose of 50 ugkg 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 09 Secondary end points include time from start of administration of sugammadex or neostigmine to recovery of TOFr to 08 and 07 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
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 20 mgkg sugammadex after the last dose of rocuronium at reappearance of T2 Patients of N group will receive a dose of 50 ugkg 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 09 Secondary end points include time from start of administration of sugammadex or neostigmine to recovery of TOFr to 08 and 07 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 182
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 32067502020-21-10 | OTHER_GRANT | Wu Jieping Medical Foundation | None |