Interaction Between Intravenous Magnesium Sulphate and Neostigmine or Sugammadex for the Reversal of a Rocuronium-induced Neuromuscular Block - A Randomized, Double Blinded, Electrophysiological Study

CCER 2016-00018

Magnesium sulphate is regularly used in perioperative medicine. During and after general anesthesia, it enhances the effect of muscle relaxants because it reduces the liberation of acetylcholine at the neuromuscular junction. When administered immediately after spontaneous recovery of a neuromuscular block (NMB), magnesium may cause a recurrence of NMB and compromise patient safety. Rocuronium is a neuromuscular blocking agent which is frequently used to facilitate intubating and surgical conditions. At the end of the procedure, there are two ways to accelerate the reversal of a neuromuscular block induced by rocuronium: 1. Administration of neostigmine, an anticholinesterase agent and competitive antagonist; 2. Administration of sugammadex, a γ-cyclodextrin compound and specific encapsulator of rocuronium. The study is done in patients receiving rocuronium and either neostigmine or sugammadex for reversal of NMB. It is hypothesized that when sugammadex is used as an antagonist of a rocuronium-induced NMB, it prevents the reappearance of NMB when magnesium is injected, because sugammadex should inactivate all remaining rocuronium molecules and restore neuromuscular reserve of the neuromuscular junctions. Further more it is hypothesized that reversal with neostigmine will not prevent a magnesium-induced recurrence of NMB to the same extent. The primary objective of the study is to show that after reversal with sugammadex there is no or only very little re-occurrence of neuromuscular block after a magnesium perfusion. Furthermore we want to show that after reversal with neostigmine there is a re-occurrence of neuromuscular block.

2019-02-11

2023-04-12

2023-04-13

Completed

Early phase I

48

Inclusion criteria Participants fulfilling all of the following inclusion criteria are eligible for the study: 1. Patients, age ≥18 to and ≤ 65 years 2. American Society of Anesthesiology \[ASA\] status I or II 3. Patient is able to read and understand the information sheet and to sign and date the consent form 4. Patient scheduled of elective surgery lasting ≥100 minutes 5. For women of childbearing age: negative pregnancy test (urinary or blood test) 6. For women of childbearing age: women on the pill should be advised to follow the missed dose advice in the product information; women using non-oral hormonal contraceptives, such as depot formulation, should be advised to use additional contraception for the next seven days Non-inclusion criteria The presence of any one of the following exclusion criteria will lead to exclusion of the participant: 1. A history of allergy or hypersensitivity to rocuronium, glycopyrronium bromide, neostigmine methylsulfate, sugammadex, or magnesium sulphate 2. Neuromuscular disease receiving medications known to influence neuromuscular function (for instance, aminoglycosides or phenytoine) 3. Preoperative medications known to influence neuromuscular function (for instance aminoglycosides, phenytoin, lidocaine) 4. Patients under toremifene, flucloxacillin and fusidic acid treatment (interaction with sugammadex cannot not be excluded) 5. Documented electrolyte abnormalities (for instance, hypermagnesemia) 6. Documented atrioventricular heart block 7. Patients with magnesium treatment within 3 days before study inclusion 8. Patients with a body mass index \<19 or \>30 kg/m2 9. Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial. 10. Patients undergoing interventions that need a continuous deep NMB (for surgical reasons). 11. Pregnant or breast feeding women

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2023-04-18