Magnesium Sulfate for Intraoperative Neuromonitoring

Recruiting at 1 trial location

Overseen By Rashmi Vandse, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Loma Linda University

Must not be taking: Magnesium

Disqualifiers: Electrolyte imbalances, Cardiac disorders, Neuromuscular disorders, Renal disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how magnesium sulfate affects the monitoring of nerve signals during complex spine and brain surgeries. The researchers aim to determine if magnesium sulfate alters the readings of nerve function tests, which help doctors ensure nerves function well during surgery. Participants will receive either magnesium sulfate (a type of mineral supplement) or a saline solution for comparison. Candidates may qualify if they plan to undergo spine or brain surgery with nerve monitoring and have not recently used magnesium. As a Phase 4 trial, this research seeks to understand how this already FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used magnesium supplements in the last 2 days before joining.

What is the safety track record for these treatments?

Research has shown that magnesium sulfate is generally safe when used in the right amounts. However, it can cause side effects such as low blood pressure and muscle weakness. Studies have found that patients often tolerate magnesium sulfate well in medical settings, especially for certain procedures. The treatment is currently being tested in a Phase 4 trial, indicating that the FDA has already approved it for other uses. This approval suggests strong evidence supporting its safety. Prospective trial participants should know that extensive research has deemed it safe for many individuals. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Magnesium sulfate is unique because it offers a different approach to enhancing intraoperative neuromonitoring. Unlike standard options that might not address neuromonitoring directly, magnesium sulfate acts as a neuromodulator, potentially stabilizing nerve signals during surgery. Researchers are excited about this treatment because it could improve the accuracy and safety of surgical procedures by maintaining more consistent neuromonitoring, which is crucial for avoiding nerve damage. Moreover, its administration as a short infusion makes it potentially easier and quicker to use during operations compared to more complex interventions.

What evidence suggests that Magnesium Sulfate is effective for intraoperative neuromonitoring?

Research has shown that magnesium sulfate, which participants in this trial may receive, can reduce pain during surgery. It lowers the need for pain medication during and after operations. Studies suggest that magnesium sulfate may also help maintain steady nerve function during surgeries that monitor nerve signals. Stable nerve function can lead to better recovery after surgery. While the effect of magnesium sulfate on specific nerve tests, such as those checking sensory and motor signals, remains under study, its overall benefits in surgery are promising. ^{3 4 5 6 7}

Who Is on the Research Team?

Rashmi Vandse, MD

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80, with good to moderate health (ASA I or II), undergoing elective spine or cranial surgery where monitoring of nerve function is planned. It's not for those with electrolyte imbalances, severe lung or kidney disease, pregnant/breastfeeding women, inadequate baseline nerve signals, heart disorders, recent magnesium use, or significant neuromuscular issues.

Inclusion Criteria

Belonging to American Society of Anesthesiologists physical status (ASA) I, II

I am scheduled for spine or brain surgery with specific nerve function monitoring.

Exclusion Criteria

My kidney function is poor, with a creatinine level over 2 mg/dl.

I do not have severe heart or rhythm problems.

I have severe lung disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Patients undergo premedication and preparation for surgery, including application of standard ASA monitors and preoxygenation

1 day

1 visit (in-person)

Intraoperative Monitoring

Patients receive general anesthesia and are monitored with IONM. Magnesium sulfate or placebo is administered, and SSEPs and MEPs are recorded at baseline and at intervals after administration

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium Sulfate
• Normal Saline

Trial Overview

The study tests the effect of a Magnesium sulfate bolus on intraoperative neurophysiological monitoring signals during surgery. Patients are randomly assigned to receive either Magnesium sulfate or a placebo (Normal Saline) in a double-blind manner to compare changes in nerve signal strength and speed.

How Is the Trial Designed?

Group I: Magnesium sulfate arm Experimental Treatment 1 Intervention

MgSo4 diluted to 20% will be administered at 40 mg/kg dosed to ideal body weight over 10min to the study arm followed by 10mg/kg/hr infusion.

Group II: Normal Saline Placebo Group 1 Intervention

20 ml of normal saline bolus will be administered to the control group over 10 mins.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Published Research Related to This Trial

A survey of 954 Brazilian anesthesiologists revealed that 35.32% use magnesium sulfate in anesthesia, primarily for its benefits in postoperative analgesia, reducing anesthetic consumption, and managing preeclampsia and seizures.

While magnesium sulfate is generally safe with a low incidence of adverse events, the most common side effects reported were hypotension and residual neuromuscular blockade, highlighting the importance of monitoring during its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use Profile of Magnesium Sulfate in Anesthesia in Brazil. Cavalcanti, IL., de Lima, FLT., da Silva, MJS., et al.[2020]

In a study of 76 patients receiving magnesium sulphate for eclampsia, the administration of a 20% solution did not increase the risk of phlebitis compared to the 2% to 8% solutions, indicating it is a safe option for treatment.

The new protocol for administering 20% magnesium sulphate resulted in fewer errors during administration, and additional strategies were identified to further enhance safety, such as preprinted orders and double-checking pump settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a simplified protocol for administration of 20% magnesium sulphate for prophylaxis and treatment of eclampsia. Palmer, L., Newby, BD.[2021]

Intra-cisternal infusion of magnesium sulfate significantly increased magnesium ion concentration in cerebrospinal fluid and demonstrated a vasodilatory effect on spastic cerebral arteries in 10 patients with symptomatic vasospasm after aneurysmal subarachnoid hemorrhage.

The treatment led to a decrease in mean arterial blood velocity in spastic arteries and resulted in good recovery for 5 out of 10 patients, suggesting potential efficacy in managing vasospasm post-SAH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial clinical experience of vasodilatory effect of intra-cisternal infusion of magnesium sulfate for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Mori, K., Yamamoto, T., Nakao, Y., et al.[2022]

A case report highlights the risks of accidental administration of magnesium sulfate in the subarachnoid space during a cesarean operation, which initially caused warm sensations and cutaneous anesthesia in the patient.

Despite the initial complications, the patient recovered muscle strength within 8-10 hours post-surgery without any neurological symptoms, emphasizing the importance of careful administration and double-checking before injections to prevent such errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accidental intrathecal injection of magnesium sulfate for cesarean section. Gilani, MT., Zirak, N., Razavi, M.[2020]

Two pregnant women in labor accidentally received magnesium sulfate in their epidural space, with each receiving about 9 mg of the drug.

Neither woman showed any signs of neurological toxicity from the error, and after correcting the mistake, they achieved satisfactory pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inadvertent administration of magnesium sulfate through the epidural catheter: report and analysis of a drug error. Goodman, EJ., Haas, AJ., Kantor, GS.[2005]

In a study of 75 obese patients undergoing laparoscopic surgery, magnesium sulfate significantly reduced postoperative pain and morphine consumption compared to a control group that did not receive the drug.

The method of calculating magnesium sulfate dosage (using actual body weight or corrected ideal body weight) did not affect the outcomes, indicating that both dosing strategies are equally effective for analgesia in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategy for Calculating Magnesium Sulfate Dose in Obese Patients: A Randomized Blinded Trial. Silva Filho, SE., Klinsky, OS., Gonzalez, MAMC., et al.[2022]

In a study of 18 patients undergoing surgery for cerebral aneurysms, magnesium sulfate infusion significantly increased brain tissue oxygen tension (PtO2) by 34%, suggesting it enhances oxygen delivery to brain tissue.

Magnesium also reduced the severity of tissue hypoxia during temporary artery occlusion, as evidenced by a slower decline in PtO2 compared to the control group, indicating its potential protective effects during ischemic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnesium sulfate for brain protection during temporary cerebral artery occlusion. Chan, MT., Boet, R., Ng, SC., et al.[2019]

In a study involving 9 patients with intracranial hypertension, intravenous magnesium sulfate infusion significantly increased plasma ionized magnesium levels but did not affect cerebrospinal fluid (CSF) magnesium concentrations.

This suggests that while magnesium sulfate can elevate magnesium in the bloodstream, it may not effectively penetrate the central nervous system, raising questions about its potential neuroprotective effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous magnesium sulfate does not increase ventricular CSF ionized magnesium concentration of patients with intracranial hypertension. Brewer, RP., Parra, A., Borel, CO., et al.[2019]

A single intravenous bolus of 60 mg/kg magnesium sulfate (MgSO4) significantly increases magnesium levels in the cerebrospinal fluid (CSF) of neurosurgical patients, particularly noticeable after 90 minutes, indicating its potential neuroprotective effects.

The study found that changes in plasma magnesium levels do not directly correlate with changes in CSF magnesium concentrations, suggesting that monitoring plasma levels alone may not accurately reflect the neuroprotective availability of magnesium in the CSF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebrospinal fluid passage of intravenous magnesium sulfate in neurosurgical patients. Fuchs-Buder, T., Tramèr, MR., Tassonyi, E.[2019]

In a study involving 40 men undergoing prostate surgery, the use of magnesium sulfate (MgSO4) for wound infiltration significantly reduced the need for tramadol, a pain medication, compared to intravenous MgSO4 administration.

Both methods of MgSO4 delivery resulted in similar pain scores, indicating effective pain management without any observed side effects from either route of administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy. Tauzin-Fin, P., Sesay, M., Svartz, L., et al.[2018]

Magnesium sulfate is widely used in obstetrics for preventing seizures in women with preeclampsia and for stopping preterm labor, but it carries a risk of accidental overdose that can harm both mothers and babies.

Despite its routine use, vigilance is essential to ensure safety, and following the recommendations in this article can help reduce the risk of overdose and improve error detection before serious harm occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety. Simpson, KR., Knox, GE.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8509453/

Magnesium Sulfate Enables Patient Immobilization during ...

We investigated the effect of intraoperative magnesium sulfate (MgSO 4 ) on acute pain intensity, analgesic consumption and intraoperative neurophysiological ...

2.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT04938765/effect-of-magnesium-sulfate-bolus-on-intraoperative-neuromonitoring

Effect of Magnesium Sulfate Bolus on Intraoperative ...

This is a prospective, double blind, randomized placebo controlled trial to study the effect of Magnesium sulfate bolus on the amplitude and latency of ...

3.

researchgate.net

researchgate.net/publication/389557967_Effect_of_perioperative_magnesium_sulfate_on_neurological_outcome_in_neurosurgical_patients_a_randomized_double-blind_controlled_trial

Effect of perioperative magnesium sulfate on neurological ...

Effect of perioperative magnesium sulfate on neurological outcome in neurosurgical patients: a randomized double-blind controlled trial.

4.

thieme-connect.com

thieme-connect.com/products/ejournals/abstract/10.1055/s-0043-1764455

Efficacy of Intraoperative Neuromonitoring during the ...

IONM shows potential in ensuring stable postoperative neurological outcomes in most patients; however, its clinical use and supportive guidelines remain ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9225065/

Magnesium Sulfate and Cerebral Oxygen Saturation in Mild ...

Nevertheless, MgSO4 helped the postoperative pain intensity, reduce the amount of intraoperative and postoperative analgesics administered, and ...

6.

withpower.com

withpower.com/trial/magnesium-sulfate-for-intraoperative-neuromonitoring-79d97

Magnesium Sulfate for Intraoperative Neuromonitoring

Magnesium sulfate is generally considered safe when used at recommended doses, but it can cause side effects like low blood pressure, muscle weakness, and pain ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04938765?aggFilters=phase%3A4+3%2CstudyType%3Aint

Effect of Magnesium Sulfate Bolus on Intraoperative ...

Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.