Magnesium and nerve monitoring during thoracolumbar spine fusion
Pharmacokinetics and Impact of Magnesium Sulfate on Neuromonitoring in Spinal Surgery
We will see if giving intravenous magnesium during open thoracolumbar spine fusion changes motor-evoked potential monitoring in adults having the operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06975072 on ClinicalTrials.gov |
What this trial studies
During complex spine surgery, transcranial motor evoked potentials (TcMEPs) are used to monitor motor pathways in real time, but anesthetic and adjunct medications can alter signal quality. This interventional Phase 4 protocol administers intravenous magnesium sulfate during open thoracolumbar fusion with planned intraoperative neurophysiologic monitoring and records TcMEP amplitude and latency. Adults over 18 undergoing these procedures are eligible if they do not have significant cardiac, renal, hepatic, or neuromuscular disease and are not allergic to magnesium. The trial aims to determine whether intraoperative magnesium alters the integrity of TcMEP signals while providing its potential opioid-sparing benefits.
Who should consider this trial
Good fit: Adults older than 18 scheduled for open thoracolumbar fusion with planned intraoperative motor-evoked potential monitoring and without the listed cardiac, renal, hepatic, neuromuscular contraindications are ideal candidates.
Not a fit: People with significant cardiac disease, severe kidney or liver dysfunction, neuromuscular disorders, magnesium allergy, or those not undergoing neuromonitoring are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If safe for monitoring, magnesium could lower postoperative pain and opioid needs while maintaining reliable motor pathway monitoring.
How similar studies have performed: Previous research shows magnesium can reduce postoperative pain and opioid use, but its direct effects on TcMEP neuromonitoring quality are not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult patients (\>18 years of age) undergoing open thoracolumbar fusion with planned neuromonitoring Exclusion Criteria: 1. Patients with a history of significant cardiac disease (LVEF \<35%, 2nd/3rd-degree block without a pacemaker, or significant arrhythmia) 2. Patients with kidney disease (GFR \<30), or hepatic dysfunction (history of cirrhosis) 3. Allergy or sensitivity to magnesium 4. Patient with neuromuscular disease such as myasthenia graves
Where this trial is running
San Francisco, California
- University of California San Francisco Hospital — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Hemra Cil, MD — University of California, San Francisco
- Study coordinator: Hemra Cil, MD
- Email: hemra.cil@ucsf.edu
- Phone: 415-502-7846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.