Interaction Between Intravenous Magnesium Sulfate and Volatile Anesthetics Compared to Propofol. A Three-center Prospective Randomized Single-blinded Electrophysiological Study

2019-02104/CE3541

Magnesium and volatiles anesthetics both have an effect on the neuromuscular transmission. The primary objective of the study is to quantify the effect of a perfusion of intravenous magnesium on neuromuscular transmission measured by electromyography device TetraGraph device in patients undergoing general anesthesia with volatile anesthetics (desflurane, sevoflurane and isoflurane) as compared to intravenous anesthesia with propofol.

2022-11-18

2025-08-31

2025-08-31

Recruiting

Early phase I

96

Inclusion Criteria: * Patients, age 18 to 65 years inclusive * American Society of Anesthesiology \[ASA\] status I or II * Body mass index 19 - 30 kg/m2 * Patient scheduled for elective surgery lasting ≥ 60 minutes * Patient is able to read and understand the information sheet and to sign and date the consent form. * Negative urinary or serum pregnancy test (not applicable if status post hysterectomy or tubal ligation or menopausal woman) Exclusion Criteria: * Surgery with need for neuromuscular block * Contraindication for general anesthesia with laryngeal mask airway, such as gastro-oesophageal reflux. * Hypersensitivity or allergy to magnesium sulfate or propofol * Contraindication to volatile anesthetics such as malignant hyperthermia * Patients with neuromuscular disease * Patients receiving medications known to influence neuromuscular function (for instance, aminoglycosides or phenytoine) * Known electrolyte abnormalities (for instance, hypermagnesemia) * Atrioventricular heart block * Patients with magnesium treatment within 48 hours before start of study * Liver insufficiency (bilirubine \<1.5x, ALAT/ASAT\<2.5x the upper limit of normal value) * Renal insuffisancy (créatinine \<1.5x upper limit of normal value, clearance\<30ml/minute) * Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial. * Pregnant or breast-feeding women.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a three centers prospective randomized, electrophysiological, single blinded study that will include 96 patients allocated to one of four arms: one arm with propofol anesthesia and three arms with volatile anesthetics (one arm with isoflurane, one with sevoflurane and one with desflurane). Each arm will have 24 patients.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'For practical reasons it is impossible to blind the investigator who conducts the anesthesia. However, the parameters of neuromuscular block are standardized, and study outcomes will be evaluated using the data stored and displayed in theTetraGraph Viewer software. All neuromuscular measurements of the study outcomes are reproducible and objective.\n\nIn contrast, the investigator evaluating the patient in the postanesthetic care unit and for the 24 h postoperative visit will be blinded to the study group allocation.\n\nThe patient will also be blinded to the study group allocation.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 96, 'type': 'ESTIMATED'}}

2024-05-10