50 Participants Needed

Magnesium Sulfate for Intraoperative Neuromonitoring

Recruiting at 1 trial location
RV
Overseen ByRashmi Vandse, MD
Prior Safety DataThis treatment has passed at least one previous human trial

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?

Magnesium sulfate is generally considered safe when used at recommended doses, but it can cause side effects like low blood pressure, muscle weakness, and pain at the injection site. Accidental overdoses or wrong injections can lead to serious issues, so careful administration is important.36789

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

RV

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

I am between 18 and 80 years old.
Belonging to American Society of Anesthesiologists physical status (ASA) I, II
I am scheduled for spine or brain surgery with specific nerve function monitoring.

Exclusion Criteria

My kidney function is poor, with a creatinine level over 2 mg/dl.
I do not have severe heart or rhythm problems.
I have severe lung disease.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Preparation

Patients undergo premedication and preparation for surgery, including application of standard ASA monitors and preoxygenation

1 day
1 visit (in-person)

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

During surgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Magnesium Sulfate
  • Normal Saline
Trial OverviewThe study tests the effect of a Magnesium sulfate bolus on intraoperative neurophysiological monitoring signals during surgery. Patients are randomly assigned to receive either Magnesium sulfate or a placebo (Normal Saline) in a double-blind manner to compare changes in nerve signal strength and speed.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium sulfate armExperimental Treatment1 Intervention
MgSo4 diluted to 20% will be administered at 40 mg/kg dosed to ideal body weight over 10min to the study arm followed by 10mg/kg/hr infusion.
Group II: Normal SalinePlacebo Group1 Intervention
20 ml of normal saline bolus will be administered to the control group over 10 mins.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials
322
Recruited
267,000+

Findings from Research

In a study of 75 obese patients undergoing laparoscopic surgery, magnesium sulfate significantly reduced postoperative pain and morphine consumption compared to a control group that did not receive the drug.
The method of calculating magnesium sulfate dosage (using actual body weight or corrected ideal body weight) did not affect the outcomes, indicating that both dosing strategies are equally effective for analgesia in this patient population.
Strategy for Calculating Magnesium Sulfate Dose in Obese Patients: A Randomized Blinded Trial.Silva Filho, SE., Klinsky, OS., Gonzalez, MAMC., et al.[2022]
In a study involving 40 men undergoing prostate surgery, the use of magnesium sulfate (MgSO4) for wound infiltration significantly reduced the need for tramadol, a pain medication, compared to intravenous MgSO4 administration.
Both methods of MgSO4 delivery resulted in similar pain scores, indicating effective pain management without any observed side effects from either route of administration.
Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy.Tauzin-Fin, P., Sesay, M., Svartz, L., et al.[2018]
A survey of 954 Brazilian anesthesiologists revealed that 35.32% use magnesium sulfate in anesthesia, primarily for its benefits in postoperative analgesia, reducing anesthetic consumption, and managing preeclampsia and seizures.
While magnesium sulfate is generally safe with a low incidence of adverse events, the most common side effects reported were hypotension and residual neuromuscular blockade, highlighting the importance of monitoring during its use.
Use Profile of Magnesium Sulfate in Anesthesia in Brazil.Cavalcanti, IL., de Lima, FLT., da Silva, MJS., et al.[2020]

References

Strategy for Calculating Magnesium Sulfate Dose in Obese Patients: A Randomized Blinded Trial. [2022]
Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomy. [2018]
Use Profile of Magnesium Sulfate in Anesthesia in Brazil. [2020]
Initial clinical experience of vasodilatory effect of intra-cisternal infusion of magnesium sulfate for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. [2022]
Cerebrospinal fluid passage of intravenous magnesium sulfate in neurosurgical patients. [2019]
Development of a simplified protocol for administration of 20% magnesium sulphate for prophylaxis and treatment of eclampsia. [2021]
Inadvertent administration of magnesium sulfate through the epidural catheter: report and analysis of a drug error. [2005]
Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety. [2019]
Accidental intrathecal injection of magnesium sulfate for cesarean section. [2020]
Magnesium sulfate for brain protection during temporary cerebral artery occlusion. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Intravenous magnesium sulfate does not increase ventricular CSF ionized magnesium concentration of patients with intracranial hypertension. [2019]