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Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia

NCT05227716 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-03-17

No results posted yet for this study

Summary

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.

Conditions

  • Anesthesia and Analgesia
  • Magnesium Sulfate

Interventions

DRUG

Perioperative magnesium sulfate

Administration of magnesium sulfate as an adjunct in anesthesia

Sponsors & Collaborators

  • Instituto Mexicano del Seguro Social

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-12-31
Completion
2024-07-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05227716 on ClinicalTrials.gov