Magnesium Sulfate for Intraoperative Neuromonitoring
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used magnesium supplements in the last 2 days before joining.
What data supports the effectiveness of the drug Magnesium Sulfate for intraoperative neuromonitoring?
Magnesium sulfate is known to provide pain relief after surgery and reduce the need for other pain medications, as shown in studies where it was used with other drugs for pain management. It also has benefits in anesthesia, such as reducing the amount of anesthetic needed and preventing certain complications, which suggests it could be helpful during surgeries.12345
Is magnesium sulfate generally safe for use in humans?
How is magnesium sulfate used differently in intraoperative neuromonitoring compared to other treatments?
Magnesium sulfate is unique in intraoperative neuromonitoring because it is used for its potential neuroprotective effects and ability to reduce anesthetic consumption, unlike other treatments that may not offer these specific benefits. It is administered intravenously, which can increase plasma magnesium levels significantly, although it does not increase magnesium levels in the cerebrospinal fluid.2341011
Research Team
Rashmi Vandse, MD
Principal Investigator
Loma Linda University
Eligibility Criteria
This trial is for adults aged 18-80, with good to moderate health (ASA I or II), undergoing elective spine or cranial surgery where monitoring of nerve function is planned. It's not for those with electrolyte imbalances, severe lung or kidney disease, pregnant/breastfeeding women, inadequate baseline nerve signals, heart disorders, recent magnesium use, or significant neuromuscular issues.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Preparation
Patients undergo premedication and preparation for surgery, including application of standard ASA monitors and preoxygenation
Intraoperative Monitoring
Patients receive general anesthesia and are monitored with IONM. Magnesium sulfate or placebo is administered, and SSEPs and MEPs are recorded at baseline and at intervals after administration
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Magnesium Sulfate
- Normal Saline
Find a Clinic Near You
Who Is Running the Clinical Trial?
Loma Linda University
Lead Sponsor