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New treatment option for Intraoperative Neurophysiological Monitoring
Official title Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring
ClinicalTrials.gov ID: NCT04938765
What this study is testing
What is Magnesium sulfate?
Magnesium sulfate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intraoperative neurophysiological monitoring.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
You likely can't join if
- Magnesium use within the last 2 days, either intravenous or oral supplements.
- Patients with known electrolyte imbalances (Sodium \ 145 mmol/L OR Potassium \ 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...
- Severe Renal disease - serum creatinine of \> 2 mg/dl.
See the full eligibility 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...
- Magnesium use within the last 2 days, either intravenous or oral supplements.
- Patients with known electrolyte imbalances (Sodium \ 145 mmol/L OR Potassium \ 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.
The study team makes the final eligibility decision.
Where it's taking place
- Loma Linda, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Loma Linda, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.