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

Trial Summary

What is the purpose of this trial?

Intraoperative neurophysiologic monitoring (IONM) is commonly used during complex spinal surgery to monitor the integrity of neural structures and improve the perioperative safety profile. Transcranial Motor Evoked Potentials (TcMEPs) monitor the integrity of the motor pathways and are one of the most commonly used monitoring modalities in spinal surgery. Because inhaled anesthetics can negatively affect the ability to monitor TcMEPs, anesthesiologists commonly use a combination of propofol and opioids to maintain the anesthetic state. Additionally, anesthesiologists will frequently administer intravenous infusions of medications that can decrease postoperative pain and opioid use (called opioid-sparing adjuncts) because spinal surgeries result in significant postoperative pain. Despite the increasing use of these agents, there is scant clinical data about how they may affect the integrity of TcMEP monitoring. Magnesium (Mg), a N-methyl-d-aspartate receptors (NMDA) receptor antagonist, is one of the adjuncts with robust data supporting clinical efficacy to decrease pain and opioid use on TcMEPs. Mg has been used clinically for decades. The investigators commonly utilize intravenous magnesium as a component of our spinal anesthesia protocol. However, there is only a single case report that discusses the effects of Mg on TcMEPs. Here the investigators propose a prospective clinical trial to quantitatively assess the effects of various Mg plasma levels on TcMEPs. There is a lack of literature on the pharmacokinetics of magnesium in non-pregnant patients.

Research Team

Hemra Cil, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+