Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID06975072

Pharmacokinetics and Impact of Magnesium Sulfate on Neuromonitoring in Spinal Surgery

Led by University of California, San Francisco · Updated on 2025-07-08

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how magnesium affects neuromonitoring during complex spinal surgeries. The study focuses on Transcranial Motor Evoked Potentials (TcMEPs), a common tool used to monitor the motor pathways and neural integrity in real time during surgery. Because inhaled anesthetics can interfere with TcMEPs, anesthesiologists typically use intravenous propofol and opioids. Magnesium, an opioid-sparing adjunct, is widely used to reduce pain after spinal surgery, but its impact on TcMEPs is not well understood, with only one case report available so far. Participants will receive a single intravenous dose of magnesium sulfate at 30 mg/kg over 10 minutes during spinal fusion surgery. The anesthetic protocol uses propofol and remifentanil to maintain sedation and avoid interference with TcMEPs. Blood samples will be collected at multiple time points up to 12 hours after dosing to measure plasma magnesium levels and study its pharmacokinetics. The study will use standard neuromonitoring equipment already part of the surgery without adding extra procedures. During the surgery, baseline motor-evoked potentials will be recorded before magnesium administration, followed by continuous neuromonitoring. Researchers will assess how magnesium levels influence TcMEP amplitude, latency, and stimulation voltage. The primary outcomes include magnesium serum levels and pharmacokinetic parameters. Safety and effectiveness of neuromonitoring will be monitored throughout, with data collection continuing for about one year. Participation involves no extension of anesthesia time or additional invasive procedures beyond standard care.

CONDITIONS

Brief Title

Effect of Magnesium on Neuromonitoring

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (over 18 years of age) undergoing open thoracolumbar fusion with planned neuromonitoring
Not Eligible

You will not qualify if you...

  • History of significant cardiac disease (LVEF less than 35%, 2nd or 3rd-degree heart block without pacemaker, or serious arrhythmia)
  • Kidney disease with GFR less than 30 or liver cirrhosis
  • Allergy or sensitivity to magnesium
  • Neuromuscular disease such as myasthenia gravis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for consent and eligibility confirmation

Treatment

Duration - Surgery day

Participants undergo spinal surgery with general anesthesia and receive a single intravenous bolus of magnesium sulfate during the procedure to study its effect on neuromonitoring.

1 visit (in-person) on the day of surgery

Monitoring

Duration - 12 hours post-surgery

Participants have blood samples collected at multiple time points after magnesium administration to measure plasma magnesium levels and assess pharmacokinetics and neuromonitoring data.

Multiple blood draws during 12 hours after surgery

Trial Site Locations

Total: 1 location

1

University of California San Francisco Hospital

San Francisco, California, United States, 94143

Actively Recruiting

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Research Team

H

Hemra Cil, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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Published Research Related To This Trial

Perioperative Care of Patients Undergoing Major Complex Spinal Instrumentation Surgery: Clinical Practice Guidelines From the Society for Neuroscience in Anesthesiology and Critical Care.

Samuel N Blacker, Anita Vincent, Mark Burbridge...

https://pubmed.ncbi.nlm.nih.gov/34483301

Magnesium sulfate enhances non-depolarizing muscle relaxant vecuronium action at adult muscle-type nicotinic acetylcholine receptor in vitro.

Hong Wang, Qi-sheng Liang, Lan-ren Cheng...

https://pubmed.ncbi.nlm.nih.gov/21986576

Impact of intraoperative intravenous magnesium on spine surgery: A systematic review and meta-analysis of randomized controlled trials.

Lei Yue, Zeng-Mao Lin, Guan-Zhang Mu...

https://pubmed.ncbi.nlm.nih.gov/35028543

A Bolus Dose of Ketamine Reduces the Amplitude of the Transcranial Electrical Motor-evoked Potential: A Randomized, Double-blinded, Placebo-controlled Study.

Kenta Furutani, Hiroyuki Deguchi, Mari Matsuhashi...

https://pubmed.ncbi.nlm.nih.gov/31633576

Intraoperative motor evoked potential monitoring - a position statement by the American Society of Neurophysiological Monitoring.

D B Macdonald, S Skinner, J Shils...

https://pubmed.ncbi.nlm.nih.gov/24055297