Actively Recruiting

Phase 4
Age: 18Years - 80Years
All Genders
ID04938765

Randomized Placebo-Controlled Study to Evaluate the Effect of Magnesium Sulfate on Intraoperative Neuromonitoring

Led by Loma Linda University · Updated on 2026-04-24

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effect of magnesium sulfate on intraoperative neuromonitoring (IONM) during complex spine and cranial surgeries. This study aims to understand how magnesium sulfate influences the amplitude and latency of somatosensory evoked potentials (SSEPs) and motor evoked potentials (MEPs). Magnesium sulfate is used in multimodal pain management during surgery, but its impact on IONM, which helps monitor neural pathways in real-time to prevent injury, has not been studied before. The study is a double-blind, randomized, placebo-controlled trial comparing a magnesium sulfate bolus and infusion to a saline placebo. Participants undergoing surgery with planned IONM will receive a 40 mg/kg magnesium sulfate bolus over 10 minutes followed by a continuous infusion, or a saline bolus over 10 minutes. Anesthesia will be maintained with propofol and remifentanil. Baseline and repeated measurements of SSEPs and MEPs will be recorded before and after drug administration at specific time points up to 30 minutes. Participants will be monitored continuously during surgery with standard anesthesia and brain function monitors. Hemodynamic data will be collected every five minutes up to 30 minutes after drug administration. Researchers will compare changes in the amplitude and latency of SSEPs and MEPs to assess magnesium sulfate's effects on IONM. The trial lasts through the surgery and immediate monitoring period. Safety and neurological function will be closely observed throughout.

CONDITIONS

Brief Title

Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 80 years
  • American Society of Anesthesiologists physical status I or II
  • Undergoing elective spine or cranial surgery with planned intraoperative neuromonitoring including somatosensory and motor evoked potentials
Not Eligible

You will not qualify if you...

  • Magnesium use within the last 2 days, either intravenous or oral
  • Known electrolyte imbalances (sodium, potassium, magnesium outside specified ranges)
  • Severe cardiac or cardiac conduction disorders
  • Severe pulmonary disease
  • Significant neuromuscular disorders or preexisting motor or sensory deficits except mild localized neuropathies
  • Severe renal disease with serum creatinine over 2 mg/dl
  • Pregnant or breastfeeding patients
  • Unable to obtain adequate baseline intraoperative neuromonitoring recordings

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Surgery duration including up to 30 minutes post-bolus monitoring

Participants receive a magnesium sulfate or placebo bolus during surgery and are monitored with intraoperative neuromonitoring to assess the effect on nerve signals.

1 intraoperative visit

Trial Site Locations

Total: 1 location

1

Loma linda University Medical Center

Loma Linda, California, United States, 92354

Actively Recruiting

Loading map...

Research Team

R

Rashmi Vandse, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Similar Trials

Functional Endoscopic Nasal and Sinus Surgery and Anesthesia...

Magnesium Sulfate

Actively Recruiting

1 location

Effectiveness of Intraoperative Combination of Ketamine and ...

Intraoperative

Actively Recruiting

1 location

Effect of Magnesium Sulfate on Postoperative Hypercoagulabil...

Magnesium Sulfate

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Perioperative systemic magnesium to minimize postoperative pain: a meta-analysis of randomized controlled trials.

Gildasio S De Oliveira, Lucas J Castro-Alves, Jamil H Khan...

https://pubmed.ncbi.nlm.nih.gov/23669270

Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.

Masih Ebrahimy Dehkordy, Roozbeh Tavanaei, Elahe Younesi...

https://pubmed.ncbi.nlm.nih.gov/32521394

Magnesium Sulfate Reduced Opioid Consumption in Obese Patients Undergoing Sleeve Gastrectomy: a Prospective, Randomized Clinical Trial.

Nurcan Kizilcik, Ozge Koner

https://pubmed.ncbi.nlm.nih.gov/29754384

Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial.

H-J Shin, E-Y Kim, H-S Na...

https://pubmed.ncbi.nlm.nih.gov/28077538

Influence of Perioperative Serum Magnesium for Cardiac and Noncardiac Morbidity and Mortality Following Emergency Peripheral Vascular Surgery.

Joshua D Whittaker, Frederick Downes, Helga Becker...

https://pubmed.ncbi.nlm.nih.gov/30045811