Magnesium for Spinal Surgery

(MgNm Trial)

Overseen By Hemra Cil, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Disqualifiers: Cardiac disease, Kidney disease, Hepatic dysfunction, Neuromuscular disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how magnesium, a common mineral, affects monitoring during spinal surgery. Specifically, it examines its impact on Transcranial Motor Evoked Potentials, which help surgeons ensure the safety of motor pathways during the operation. The trial will explore whether magnesium can manage pain and reduce opioid use without interfering with surgery monitoring. Adults undergoing complex spinal surgery with planned neuromonitoring and no major heart, kidney, or liver issues may be eligible to participate. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how magnesium can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for this treatment?

Research has shown that magnesium, often used in spinal surgery, is generally safe. Studies have found that magnesium can help reduce pain and the need for painkillers after surgery. It also seems to lower the chances of nausea and shivering during the operation.

In previous studies, participants who received magnesium did not report serious side effects, suggesting it is usually well-tolerated. Magnesium has been used in medicine for a long time, providing extensive knowledge about its safety. However, this trial will specifically examine how magnesium affects a type of nerve monitoring during surgery.

Overall, magnesium appears to be a safe option for many patients undergoing spinal surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using magnesium for spinal surgery because it offers a novel approach to managing pain and recovery. Unlike standard treatments that often rely on opioids or other pain medications, magnesium works by modulating neural excitability and reducing inflammation, which could potentially reduce the need for conventional painkillers. Additionally, the delivery method is unique—a single intravenous bolus administered quickly—which may offer faster relief and fewer side effects compared to prolonged drug regimens. Overall, magnesium's potential to enhance recovery while minimizing opioid use is what makes it stand out in the treatment landscape for spinal surgery.

What evidence suggests that magnesium is effective for spinal surgery?

Research has shown that magnesium, which participants in this trial will receive, can reduce pain and the need for strong painkillers after spinal surgery. Studies have found that magnesium not only eases post-surgery pain but also helps with nausea and vomiting. It blocks certain signals in the brain that cause pain. Additionally, magnesium shows promise for pain relief during surgery by helping the body manage stress. It has been safely used for many years in medical practice and effectively manages pain in spinal surgeries. ^{1 2 3 4 5}

Who Is on the Research Team?

Hemra Cil, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals undergoing complex spinal surgery who can be monitored using a technique called Transcranial Motor Evoked Potentials (TcMEPs). Participants should not have conditions that interfere with TcMEP monitoring or magnesium administration.

Inclusion Criteria

I am over 18 and will have spine surgery with nerve monitoring.

Exclusion Criteria

Allergy or sensitivity to magnesium

I have a condition like myasthenia gravis affecting my muscles and nerves.

I do not have serious heart conditions like low heart pump function, certain heart block without a pacemaker, or major irregular heartbeat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous bolus of magnesium during spinal surgery, with neuromonitoring and blood sampling for pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with ongoing data collection on neuromonitoring and magnesium levels

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium

Trial Overview The study tests how different levels of magnesium sulfate in the blood affect TcMEPs during spine surgery. It aims to understand if magnesium, used to reduce pain and opioid use after surgery, impacts the monitoring of motor pathways.

How Is the Trial Designed?

Group I: Magnesium Arm Experimental Treatment 1 Intervention

A single intravenous bolus of Mg of 30mg/kg (based on ideal body weight) will be administered over a period of 10 minutes (min).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12213652/

Effectiveness and impact of intravenous magnesium sulfate in ... Intravenous magnesium sulfate demonstrated significant benefits in reducing postoperative pain and opioid consumption, while also improving verbal response and ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00527-7/fulltext

Impact of intraoperative intravenous magnesium on spine ... IIM as adjuvant analgesics showed overall benefits on spine surgery in terms of reducing analgesic requirement and postoperative nausea and vomiting.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38892833/

Efficacy and Safety of Intravenous Magnesium Sulfate in ... In conclusion, magnesium sulfate administration in spinal surgery reduced pain and opioid consumption, and prolonged orientation and verbal ...

4. cureus.com cureus.com/articles/298948-the-effects-of-magnesium-sulfate-on-postoperative-pain-in-patients-undergoing-lumbar-spinal-surgery-a-systematic-review-of-randomized-controlled-trials

The Effects of Magnesium Sulfate on Postoperative Pain in ... All in all, magnesium sulfate shows potential as an analgesic additive in lumbar surgery, aiding in postoperative pain reduction and decreased ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04161729

Effects of Intraoperative Magnesium Sulfate on ... Magnesium sulfate has been reported to be effective in perioperative pain treatment and in blunting somatic, autonomic and endocrine reflexes provoked by ...