Impact of Magnesium Sulfate on Nerve Monitoring During Surgery
Randomized and Placebo Controlled Study to Evaluate the Effect of Magnesium Sulfate on Intraoperative Neuromonitoring.
This study is testing if giving magnesium sulfate during spine and brain surgeries can improve nerve monitoring and pain management compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Loma Linda University Academic / other |
| Locations | 1 site (Loma Linda, California) |
| Trial ID | NCT04938765 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of magnesium sulfate on intraoperative neurophysiological monitoring (IONM) during spine and cranial surgeries. It is a prospective, double-blind, randomized placebo-controlled trial that aims to assess how magnesium sulfate influences the amplitude and latency of somatosensory and motor evoked potentials. By comparing the effects of magnesium sulfate to a placebo, the study seeks to provide insights into optimizing pain management and nerve monitoring during complex surgical procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 who are undergoing elective spine or cranial surgery with planned intraoperative neuromonitoring.
Not a fit: Patients with recent magnesium use, significant electrolyte imbalances, severe cardiac or pulmonary diseases, or preexisting neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of pain management during surgeries that require intraoperative neurophysiological monitoring.
How similar studies have performed: While magnesium sulfate has been studied for pain management, the specific effects on intraoperative neurophysiological monitoring have not been previously explored, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria. * Patients aged 18 to 80 years * Belonging to American Society of Anesthesiologists physical status (ASA) I, II * Undergoing elective spine or cranial surgery where intraoperative neuromonitoring including short latency somatosensory evoked potentials (SSEP or SEP) and transcranial electrical muscle motor evoked potentials recording from muscles (TceMEP or TcMEP or mMEP or MEP) is planned. Exclusion Criteria: * Magnesium use within the last 2 days, either intravenous or oral supplements. * Patients with known electrolyte imbalances (Sodium \<135 or \>145 mmol/L OR Potassium \< 3.5 or \> 5.0 mmol/L, Magnesium \>1.2 mmol/L. * Severe cardiac or cardiac conduction disorders. * Severe pulmonary disease. * Patients with significant neuromuscular disorders or preexisting motor or sensory deficits other than focal upper limb neuropathy or focal cervical radiculopathy or mild cervical myelopathy. * Severe Renal disease - serum creatinine of \> 2 mg/dl. * Pregnant or breastfeeding patients. * Unable to obtain adequate baseline SSEPs and MEPs.
Where this trial is running
Loma Linda, California
- Loma linda University Medical Center — Loma Linda, California, United States (Recruiting)
Study contacts
- Principal investigator: Rashmi Vandse, MD — Loma Linda University
- Study coordinator: Rashmi Vandse, MD
- Email: rvandse@llu.edu
- Phone: 9095584000
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.