Clinical Response to Magnesium Sulfate as an Adjunct in the Anesthesia

NCT05227716 | Unknown Phase 4 DMC

• 1 other identifier: R-2021-902-040
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Magnesium Sulfate; Anesthesia; Analgesia; Pain, Postoperative; Receptors, N-Methyl-D-Aspartate

Outcome Measures

Primary Outcomes (9)

• Changes in postoperative analgesia over 24 hours

  Postoperative pain intensity reported by the participant using the visual analog scale after intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).

  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

  Time (minutes) to request analgesia after coming out of anesthesia after intravenous infusion of magnesium sulfate or placebo (NaCl at 0.9%).

  24 hours after departure from anesthesia

• Hemodynamic stability

  Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) intraoperatively after or during intravenous infusion of magnesium sulfate or normal saline (0.9% NaCl) were combined to report hemodynamic stability. Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) of less than 20% without the need to administer atropine, ephedrine or other positive chronotropic agents and/or vasoactive agents are considered criteria of hemodynamic stability.

  180 minutes intraoperatively

• Interaction with neuromuscular blockers (BNM): Onset time

  Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II: \- Onset time (OT): Time elapsed from the administration of BNM to obtaining a depression in the monitored motor response of between 80 to 100% with the T1 stimulus pattern of TOF.

  180 minutes intraoperatively

• Interaction with neuromuscular blockers (BNM):Clinical effect time

  Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II: \- Clinical effect time: Time elapsed from administration of BNM until 25% is recovered in the monitored motor response measured with TOF as T1\> 25% or ST\> 25%.

  180 minutes intraoperatively

• Interaction with neuromuscular blockers (BNM): Recovery index (RI)

  Parameters measured per train of four after administration of the non-depolarizing muscle relaxant according to the parameters established in the current guidelines for good clinical research practices in pharmacodynamic studies of neuromuscular blocking agents II: \- Recovery index (RI): Time elapsed between recovery of 25% and 75% of T1 from TOF.

  180 minutes intraoperatively

• Adverse reactions to magnesium sulfate

  Adverse reactions to the perioperative administration of parenteral magnesium sulfate that derive from magnesium poisoning or alterations in the administration site. Administration site alterations (injection site pain, hypothermia, vasodilation with a sensation of heat). Nervous system (loss of tendon reflex, headache, dizziness, coma, drowsiness and confusion, CNS depression, respiratory paralysis). Cardiovascular system (circulatory collapse, arrhythmias, cardiac arrest). Respiratory system (respiratory depression secondary to neuromuscular block). Gastrointestinal system (nausea and vomiting). Musculoskeletal and connective tissue system (muscle weakness). Others (problems with speech, vision, excessive sweating, thirst, or others not reported).

  From the start of the magnesium sulfate infusion until 24 hours after leaving anesthesia

• Adverse reactions to anesthesia

  Side and adverse effects associated with the use of anesthetic drugs. Nausea, vomiting, itching, chills, urinary retention, arrhythmias, laryngeal or bronchial spasm.

  180 minutes intraoperatively up to 24 hours after discharge from anesthesia

• Number of participants carrying polymorphisms related to perioperative clinical response to magnesium sulfate

  Determination of polymorphisms related to the pharmacokinetics of opioids (gene CYP3A4/\*16, CYP3A4/\*1B), the NMDA receptor (GENE NR1/GRIN1, NR2/GRIN2A, NR2B/GRIN2B, NR3A/GRIN3A, NR3B/GRIN3B), and magnesium transporters (gene CNNM2, TRPM6, SLC41A1, SLC41A2).

  During the 3-year duration of the study

Secondary Outcomes (6)

• Conditions for endotracheal intubation

  5 minutes after the administration of BNM

• Consumption of intraoperative analgesics

  180 minutes intraoperatively

• Postoperative analgesic consumption

  From exit from anesthesia up to 24 hours

• Consumption of neuromuscular relaxant

  180 minutes intraoperatively

• Hypnotic use

  180 minutes intraoperatively

Other Outcomes (1)

• Serum magnesium

  Before IV infusion of MgS04 or placebo (NaCl at 0.9%) and 24 hours after coming out of anesthesia

Study Arms (2)

Magnesium sulphate

EXPERIMENTAL

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

Drug: Perioperative magnesium sulfate

Placebo

PLACEBO COMPARATOR

Administration of intravenous physiological solution (NaCl 0.9%) as a complement to anesthesia. Dose: equivalent to that administered in the MgSO4 group

Drug: Perioperative magnesium sulfate

Interventions

Perioperative magnesium sulfate DRUG

Administration of magnesium sulfate as an adjunct in anesthesia

Magnesium sulphate; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (2)

Instituto Mexicano Del Seguro Social

Gómez Palacio, Durango, 35025, Mexico

RECRUITING

Lilia Edith Luque-Esparza

Gómez Palacio, Durango, 35025, Mexico

NOT YET RECRUITING

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Central Study Contacts

Lilia E Luque-Esparza, Dra.

CONTACT

+528715796441; dra.luque@gmail.com

Dealmy Delgadillo-Guzmán, Dra.

CONTACT

+528711324472; dealmyelgadilloguz@uadec.edu.mx

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple blind: Participants and researchers will be unaware of the type of intervention used (administration of MgSO4 or Placebo).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: * Clinical trial: An intervention will be carried out in the population to be studied for the purpose of the research and there will be a control group. * 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.

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: February 7, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

ME (2)