NCT06975072 Effect of Magnesium on Neuromonitoring
| NCT ID | NCT06975072 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Condition | Spine |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2025-07-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Hemra Cil, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06975072 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06975072 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06975072 currently recruiting?
Yes, NCT06975072 is actively recruiting participants. Contact the research team at hemra.cil@ucsf.edu for enrollment information.
Where is the NCT06975072 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06975072 clinical trial?
NCT06975072 is sponsored by University of California, San Francisco. The principal investigator is Hemra Cil, MD at University of California, San Francisco. The trial plans to enroll 20 participants.