Effect of Magnesium on Neuromonitoring

NCT06975072 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-43430
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative neurophysiologic monitoring (IONM) is commonly used during complex spinal surgery to monitor the integrity of neural structures and improve the perioperative safety profile. Transcranial Motor Evoked Potentials (TcMEPs) monitor the integrity of the motor pathways and are one of the most commonly used monitoring modalities in spinal surgery. Because inhaled anesthetics can negatively affect the ability to monitor TcMEPs, anesthesiologists commonly use a combination of propofol and opioids to maintain the anesthetic state. Additionally, anesthesiologists will frequently administer intravenous infusions of medications that can decrease postoperative pain and opioid use (called opioid-sparing adjuncts) because spinal surgeries result in significant postoperative pain. Despite the increasing use of these agents, there is scant clinical data about how they may affect the integrity of TcMEP monitoring. Magnesium (Mg), a N-methyl-d-aspartate receptors (NMDA) receptor antagonist, is one of the adjuncts with robust data supporting clinical efficacy to decrease pain and opioid use on TcMEPs. Mg has been used clinically for decades. The investigators commonly utilize intravenous magnesium as a component of our spinal anesthesia protocol. However, there is only a single case report that discusses the effects of Mg on TcMEPs. Here the investigators propose a prospective clinical trial to quantitatively assess the effects of various Mg plasma levels on TcMEPs. There is a lack of literature on the pharmacokinetics of magnesium in non-pregnant patients.

Conditions

Spine; Pain; Spine Surgery; Spine Surgery With Neuromonitoring; Spine Surgery With Motor Evoked Potential Monitoring; Spine Fusion

Keywords

spine; spine surgery; spine fusion; magnesium; neuromonitoring; motor evoked potential monitoring

Outcome Measures

Primary Outcomes (5)

• Serum Magnesium level

  Serum magnesium level will be measured by UCSF Lab.

  Through study completion, an average of 1 year

• Magnesium- Pharmakokinetics Clearance (CL)

  Serum magnesium level will be measured by UCSF Lab. Then the investigators will run the Pharmakokinetics clearance (CL) data with the levels.

  Through study completion, an average of 1 year

• Magnesium- Pharmacokinetics central volume of distribution (Vc)

  Serum magnesium level will be measured by UCSF Lab. Then the investigators will run the Pharmacokinetics Central volume of distribution (Vc) data with the levels.

  Through study completion, an average of 1 year

• Magnesium- Pharmakokinetics (PK) intercompartmental clearance (Q)

  Serum magnesium level will be measured by UCSF Lab. Then the investigators will run the PK intercompartmental clearance (Q) data with the levels.

  Through study completion, an average of 1 year

• Magnesium- Pharmakokinetics peripheral volume of distribution (Vp)

  Serum magnesium level will be measured by UCSF Lab. Then the investigators will run the PK peripheral volume of distribution (Vp) data with the levels.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Neuromonitoring data-Stimulation voltage

  Through study completion, an average of 1 year

• Neuromonitoring data- motor-evoked potential (MEP) amplitude

  Through study completion, an average of 1 year

• Neuromonitoring data- Motor Evoked Potential (MEP) Latency

  Through study completion, an average of 1 year

Study Arms (1)

Magnesium Arm

EXPERIMENTAL

A single intravenous bolus of Mg of 30mg/kg (based on ideal body weight) will be administered over a period of 10 minutes (min).

Drug: Magnesium sulfate administration

Interventions

Magnesium sulfate administration DRUG

A single intravenous bolus of Mg of 30mg/kg (based on ideal body weight) will be administered over a period of 10 minutes (min).

Magnesium Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years of age) undergoing open thoracolumbar fusion with planned neuromonitoring

You may not qualify if:

• Patients with a history of significant cardiac disease (LVEF \<35%, 2nd/3rd-degree block without a pacemaker, or significant arrhythmia)
• Patients with kidney disease (GFR \<30), or hepatic dysfunction (history of cirrhosis)
• Allergy or sensitivity to magnesium
• Patient with neuromuscular disease such as myasthenia graves

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco Hospital

San Francisco, California, 94143, United States

RECRUITING

Related Publications (10)

• Blacker SN, Vincent A, Burbridge M, Bustillo M, Hazard SW, Heller BJ, Nadler JW, Sullo E, Lele AV; Society for Neuroscience in Anesthesiology and Critical Care. Perioperative Care of Patients Undergoing Major Complex Spinal Instrumentation Surgery: Clinical Practice Guidelines From the Society for Neuroscience in Anesthesiology and Critical Care. J Neurosurg Anesthesiol. 2022 Jul 1;34(3):257-276. doi: 10.1097/ANA.0000000000000799. Epub 2021 Sep 6.

  PMID: 34483301 BACKGROUND

• Johnson T, Kale EB, Husain AM. Magnesium Sulfate-Induced Motor Evoked Potential Changes. Neurodiagn J. 2018;58(2):83-90. doi: 10.1080/21646821.2018.1469336.

  PMID: 29923809 BACKGROUND

• Wang H, Liang QS, Cheng LR, Li XH, Fu W, Dai WT, Li ST. Magnesium sulfate enhances non-depolarizing muscle relaxant vecuronium action at adult muscle-type nicotinic acetylcholine receptor in vitro. Acta Pharmacol Sin. 2011 Dec;32(12):1454-9. doi: 10.1038/aps.2011.117. Epub 2011 Oct 10.

  PMID: 21986576 BACKGROUND

• Yue L, Lin ZM, Mu GZ, Sun HL. Impact of intraoperative intravenous magnesium on spine surgery: A systematic review and meta-analysis of randomized controlled trials. EClinicalMedicine. 2022 Jan 5;43:101246. doi: 10.1016/j.eclinm.2021.101246. eCollection 2022 Jan.

  PMID: 35028543 BACKGROUND

• Martell BA, Arnsten JH, Krantz MJ, Gourevitch MN. Impact of methadone treatment on cardiac repolarization and conduction in opioid users. Am J Cardiol. 2005 Apr 1;95(7):915-8. doi: 10.1016/j.amjcard.2004.11.055.

  PMID: 15781034 BACKGROUND

• Furutani K, Deguchi H, Matsuhashi M, Mitsuma Y, Kamiya Y, Baba H. A Bolus Dose of Ketamine Reduces the Amplitude of the Transcranial Electrical Motor-evoked Potential: A Randomized, Double-blinded, Placebo-controlled Study. J Neurosurg Anesthesiol. 2021 Jul 1;33(3):230-238. doi: 10.1097/ANA.0000000000000653.

  PMID: 31633576 BACKGROUND

• Tramer MR, Schneider J, Marti RA, Rifat K. Role of magnesium sulfate in postoperative analgesia. Anesthesiology. 1996 Feb;84(2):340-7. doi: 10.1097/00000542-199602000-00011.

  PMID: 8602664 BACKGROUND

• Herdmann J, Deletis V, Edmonds HL Jr, Morota N. Spinal cord and nerve root monitoring in spine surgery and related procedures. Spine (Phila Pa 1976). 1996 Apr 1;21(7):879-85. doi: 10.1097/00007632-199604010-00023.

  PMID: 8779023 BACKGROUND

• Sloan TB, Heyer EJ. Anesthesia for intraoperative neurophysiologic monitoring of the spinal cord. J Clin Neurophysiol. 2002 Oct;19(5):430-43. doi: 10.1097/00004691-200210000-00006.

  PMID: 12477988 BACKGROUND

• Macdonald DB, Skinner S, Shils J, Yingling C; American Society of Neurophysiological Monitoring. Intraoperative motor evoked potential monitoring - a position statement by the American Society of Neurophysiological Monitoring. Clin Neurophysiol. 2013 Dec;124(12):2291-316. doi: 10.1016/j.clinph.2013.07.025. Epub 2013 Sep 18.

  PMID: 24055297 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hemra Cil, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hemra Cil, MD

CONTACT

415-502-7846; hemra.cil@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: May 16, 2025
• Study Start: July 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)