Magnesium Sulfate in Bariatric Surgery

NCT05843812 | Unknown DMC

• 1 other identifier: C.B/01-04-23
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Weight loss surgery, also known as bariatric surgery, has been around since the 1950s and since its inception has been shown to successfully achieve significant and sustainable weight loss in a large number of patients who undergo this intervention, as well , if a beneficial impact is observed in the management of metabolic disorders, such as type 2 diabetes mellitus and hyperlipidemia. After bariatric surgery, patients are at risk of narcotic-related side effects.(2) Because of this, pain management strategies must be implemented to reduce the consumption of narcotic medications. Some studies have reported that a multimodal analgesic regimen can reduce the consumption of postoperative narcotics, as well as the therapy requirements to control postoperative nausea and vomiting. It has also been reported that excess body mass is associated with changes in mineral levels in the body, particularly hypomagnesemia , a condition that is also common in hospitalized patients (Hansen \& Bruserud 2018), and has a high incidence in the perioperative environment. Magnesium sulfate (MgSO4) has multiple desirable effects in an anesthetic procedure. It is an antagonist of the N-methyl-d-aspartic acid (NMDA) receptor, which is why it produces an analgesic effect related to the prevention of central sensitization caused by peripheral tissue injury. In addition, other relevant clinical effects of MgSO4 have been reported in anesthesiology, such as its effect as a CNS depressant, modulation of the hemodynamic response, reduction of the intraoperative requirements of anesthetics, analgesics, and muscle relaxants. As well as the potentiation of the effect of non-depolarizing muscle relaxants. The role of magnesium in the body and its pharmacological properties continue to be studied and knowledge of its pharmacological, clinical and physiological characteristics has become essential for the anesthesiologist. There are no previous studies that allow establishing an optimal therapeutic scheme considering all the perioperative clinical effects of MgSO4 and that evaluate the role of genetic variability in pain perception and response to treatment in bariatric surgery.

Conditions

Anesthesia and Analgesia; Magnesium Sulfate; Bariatric Surgery Candidate

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Changes in postoperative analgesia over 24 hours

  Postoperative pain intensity reported by the participant using the visual analog scale after bariatric surgery

  [Time Frame: 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 bariatric surgery

  [Time Frame: 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 bariatric surgery were combined to report hemodynamic stability. Measurements of heart rate and mean arterial pressure will be added to arrive at a reported value (hemodynamic stability: yes or no). Changes in heart rate (beats per minute) and mean systemic arterial pressure (mmHg) less than 20% with respect to baseline values will be considered as criteria for hemodynamic stability, without the need to administer atropine, ephedrine or other positive chronotropic agents and / or vasoactive agents.

  [Time Frame: 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.

  [Time Frame: 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%.

  [Time Frame: 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.

  [Time Frame: 180 minutes intraoperatively]

Secondary Outcomes (9)

• Adverse reactions to magnesium sulfate

  [Time Frame: From the start of the magnesium sulfate infusion until 24 hours after leaving anesthesia]

• Adverse reactions to anesthesia

  [Time Frame: 180 minutes intraoperatively up to 24 hours after discharge from anesthesia]

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

  [Time Frame: During the 2-year duration of the study]

• Conditions for endotracheal intubation

  5 minutes after the administration of BNM

• Consumption of intraoperative analgesics

  180 minutes intraoperatively

Other Outcomes (2)

• Serum magnesium

  Before IV infusion of MgS04 and 24 hours after coming out of anesthesia

• Intracellular magnesium

  Before IV infusion of MgS04 and 24 hours after coming out of anesthesia

Study Arms (2)

Magnesium sulphate

Patients who received preoperative infusion with magnesium sulfate as part of their anesthetic management

Drug: Magnesium Sulfate 10 MG/ML

No Magnesium sulphate

Patients who did not receive preoperative magnesium sulfate infusion as part of their anesthetic management

Interventions

Magnesium Sulfate 10 MG/ML DRUG

Patients who received preoperative infusion with magnesium sulfate as part of their anesthetic management

Magnesium sulphate

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men and women over the age of 18, scheduled for bariatric surgery

You may qualify if:

• Patients scheduled for bariatric surgery under general o anesthesia at Hospital universitario de la Facultad de Medicina de la Universidad Autonoma de Coahuila
• Physical state ASA 2 y 3
• 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 (1)

Lilia Edith Luque-Esparza

Gómez Palacio, Durango, 35025, Mexico

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood dna

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Magnesium Sulfate

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 6, 2023
• Study Start: April 21, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

ME (1)