Clinical trial

Evaluation of the Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia

Name
R-2021-902-040
Description
Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure, including modulation of the hemodynamic response to surgical stress, perioperative anesthetic and analgesic effect, potentiation of neuromuscular blockade, and central nervous system depression. MgSO4 is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, therefore it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue damage. Objective. To evaluate the perioperative clinical response to MgSO4 as an adjunct to anesthesia. Material and method. Randomized, triple-blind clinical trial that will include men and women over 18 years of age, scheduled for surgery under general or regional anesthesia. After accepting and signing the informed consent, all patients will be subjected to the same pre, trans and postoperative protocol and will be assigned to 2 groups according to the intravenous administration of MgSO4 (placebo and MgSO4). A brief preoperative medical history will be taken, a peripheral blood sample will be taken to determine preoperative serum Mg, the clinical effect of MgSO4 on trans and postoperative analgesia (EVAD), hemodynamic stability (blood pressure (BP) and heart rate ( HR)), motor and neuromuscular block time (Bromage and TOF), and recovery time. The presence of adverse reactions to anesthesia (nausea, vomiting, chills, pruritus, urinary retention, arrhythmias, laryngeal or bronchial spasm) and those secondary to the administration of Mg, SO4, as well as the total doses of all drugs used during the perioperative. The data will be analyzed in the SPSS software.
Trial arms
Trial start
2022-10-01
Estimated PCD
2023-12-31
Trial end
2024-07-31
Status
Recruiting
Phase
Early phase I
Treatment
Perioperative magnesium sulfate
Administration of magnesium sulfate as an adjunct in anesthesia
Arms:
Magnesium sulphate, Placebo
Size
104
Primary endpoint
Changes in postoperative analgesia over 24 hours
15 minutes after coming out of anesthesia, 2, 4, 6 and 24 hours after coming out of anesthesia
Time to first request for pain reliever
24 hours after departure from anesthesia
Hemodynamic stability
180 minutes intraoperatively
Interaction with neuromuscular blockers (BNM): Onset time
180 minutes intraoperatively
Interaction with neuromuscular blockers (BNM):Clinical effect time
180 minutes intraoperatively
Interaction with neuromuscular blockers (BNM): Recovery index (RI)
180 minutes intraoperatively
Adverse reactions to magnesium sulfate
From the start of the magnesium sulfate infusion until 24 hours after leaving anesthesia
Adverse reactions to anesthesia
180 minutes intraoperatively up to 24 hours after discharge from anesthesia
Number of participants carrying polymorphisms related to perioperative clinical response to magnesium sulfate
During the 3-year duration of the study
Eligibility criteria
Inclusion Criteria: * Patients scheduled for elective surgery under general or regional anesthesia at Hospital General de Zona No. 51. * Physical state ASA 1 and 2 * BMI 18-30 kg / m2 * Acceptance and signing of the informed consent. Exclusion Criteria: * Treatment with calcium or magnesium channel blockers * Drug use or alcoholism referred by the patient in the questioning * Neurological diseases * Myopathy * Intracardiac block * Renal insufficiency * Liver failure * Pregnancy * Hematological disorders * Contraindications to the use of magnesium sulfate (hypersensitivity to the active principle or to any of the excipients, concomitant use with quinidine derivatives, tachycardia, heart failure, myocardial injury, infarction). Elimination criteria: * Survey with incomplete data corresponding to the study variables. * Revocation of informed consent or decision to withdraw by of the patient. * Loss to follow-up
Protocol
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Updated at
2023-03-17

1 organization

1 product

2 indications