Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia
NCT ID: NCT05227716
Last Updated: 2023-03-17
Study Results
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Basic Information
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UNKNOWN
PHASE4
104 participants
INTERVENTIONAL
2022-10-01
2024-07-31
Brief Summary
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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.
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Detailed Description
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Personal data, background and sociodemographic variables will be collected in a data collection sheet. Subsequently, anthropometric measurements will be made to determine weight, height, body mass index and blood pressure.
Peripheral venous blood samples will be taken in the operating room for the determination of pre and postoperative serum Mg and other analyzes.
Each participant will receive standard and continuous monitoring (electrocardiogram, oxygen saturation, blood pressure, capnography, temperature and TOF) and an intravenous access will be established. The MgSO4 group will receive 30 mg / kg of magnesium sulfate intravenously over a period of 15 minutes before induction of anesthesia and 10 mg / kg / h by continuous intravenous infusion during the operation. The control group (placebo) will receive 0.9% NaCl in the same volume as the study drug.
In procedures under general anesthesia, a standard protocol with propofol 2 mg / kg (IV), fentanyl 2 μg / kg (IV) and cisatracurium 0.2 mg / kg (IV) will be applied. Anesthesia will be maintained with 100% oxygen, and 0.5 to 4 vol% sevoflurane, to achieve a mean alveolar concentration (MAC) of 50%. Maintenance doses of fentanyl will be added to the anesthesia regimen as needed. The maintenance dose of cisatracurium will be administered according to the MNM with TOF. The total doses of the drugs used will be recorded. In cases with neuraxial regional anesthesia, a standard protocol with 10 mg heavy bupivacaine and subarachnoid buprenorphine 60 mcg will be applied.
Hemodynamic parameters will be recorded at baseline (before administration of magnesium sulfate or 0.9% isotonic saline solution and subsequently every 5 minutes during surgery, up to 180 minutes after drug administration.
Low blood pressure during surgery, defined as a mean blood pressure value \<50 mmHg, will be treated with a 5 mg bolus of ephedrine given intravenously or norepinephrine by IV infusion for persistent hypotension (this is the standard anesthetic management of variations in hemodynamic stability). Low heart rate during surgery, defined as \<50 beats per minute, will be treated with atropine at 10 mcg / kg intravenously.
The time until the MNM with TOF indicates the suitability of the neuromuscular block for intubation will be recorded, and the intubation conditions will be evaluated.
The postoperative analgesic protocol will include ketorolac 30mg IV, tramadol 100mg IV, or lysine clonixinate 100mg in case of allergy to ketorolac. Buprenorphine will be administered subcutaneously at a dose of 2 mcg / kg as rescue analgesia only when necessary.
As an adjunct to anesthesia, dexamethasone 8 mg IV, metoclopramide 10 mg IV, ondansetron 100 mcg / kg and omeprazole 40 mg IV will be administered.
Post-operative pain assessment will be performed by EVAD upon exiting anesthesia and at 2, 4, 6, and 24 hours.
The time elapsed until the first request for additional analgesic by the patient, and the total consumption of postoperative analgesics will be recorded, recording it as morphine equivalents.
All the information about all the drugs administered to the patient during their perioperative stay will be collected.
Episodes of nausea, vomiting, itching, chills, arrhythmias, laryngeal or bronchial spasm will be recorded during and after coming out of anesthesia and at the end of the hospital stay.
Satisfaction in recovery from anesthesia will be assessed at 24 hours by delivering a self-report questionnaire to patients.
Finally, the data will be captured in a database for subsequent statistical analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Triple blind: Participants and researchers will be unaware of the type of intervention used (administration of MgSO4 or Placebo).
* Randomized: A list of random numbers will be used to assign patients to study groups.
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Magnesium sulphate
Administration of intravenous MgSO4 as an adjunct to anesthesia.
Dose: 30 mg / kg of MgSO4 IV 15 minutes before induction of anesthesia and 10 mg / kg / h in continuous IV infusion during the operation
Perioperative magnesium sulfate
Administration of magnesium sulfate as an adjunct in anesthesia
Placebo
Administration of intravenous physiological solution (NaCl 0.9%) as a complement to anesthesia.
Dose: equivalent to that administered in the MgSO4 group
Perioperative magnesium sulfate
Administration of magnesium sulfate as an adjunct in anesthesia
Interventions
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Perioperative magnesium sulfate
Administration of magnesium sulfate as an adjunct in anesthesia
Eligibility Criteria
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Inclusion Criteria
* Physical state ASA 1 and 2
* BMI 18-30 kg / m2
* Acceptance and signing of the informed consent.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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Lilia Edith Luque Esparza
Principal Investigator
Locations
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Instituto Mexicano Del Seguro Social
Gómez Palacio, Durango, Mexico
Lilia Edith Luque-Esparza
Gómez Palacio, Durango, Mexico
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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R-2021-902-040
Identifier Type: -
Identifier Source: org_study_id
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