NCT04938765 Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring
| NCT ID | NCT04938765 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Loma Linda University |
| Condition | Intraoperative Neurophysiological Monitoring |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-03-18 |
| Primary Completion | 2027-03 |
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 50 participants in total. It began in 2022-03-18 with a primary completion date of 2027-03.
⚠ 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
Magnesium Sulfate(MgSo4) is increasingly being used as part of the multimodal pain regimen in the perioperative period. The intraoperative neurophysiological monitoring (IONM) is utilized in complex spine and cranial surgeries to assess the functional integrity of the neural pathways. The effect of Magnesium sulfate on IONM has not been studied. This is a prospective, double blind, randomized placebo controlled trial to study the effect of Magnesium sulfate bolus on the amplitude and latency of somatosensory(SSEPs) and motor evoked potentials(MEPs) in patients undergoing surgery requiring IONM.
Eligibility 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.
Contact & Investigator
Rashmi Vandse, MD
PRINCIPAL INVESTIGATOR
Loma Linda University
Frequently Asked Questions
Who can join the NCT04938765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intraoperative Neurophysiological Monitoring. 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 NCT04938765 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 NCT04938765 currently recruiting?
Yes, NCT04938765 is actively recruiting participants. Contact the research team at rvandse@llu.edu for enrollment information.
Where is the NCT04938765 trial being conducted?
This trial is being conducted at Loma Linda, United States.
Who is sponsoring the NCT04938765 clinical trial?
NCT04938765 is sponsored by Loma Linda University. The principal investigator is Rashmi Vandse, MD at Loma Linda University. The trial plans to enroll 50 participants.