Recruiting

Magnesium

Sponsor:

UCLA

Code:

NCT06975072

Conditions

Spine

Pain

Spine Surgery

Spine Surgery With Neuromonitoring

Spine Surgery With Motor Evoked Potential Monitoring

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium sulfate administration

Study Details

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

Study ID

NCT06975072

Start date

Jul 1, 2025

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Magnesium Arm

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

no intervention: Control group

Control group will have the same anesthesia protocol without Mg administration

Interventions

Magnesium sulfate administration

A single intravenous bolus of Mg of 30mg/kg (based on ideal body weight) will be administered over a period of 10 minutes (min). Control group will not have any Mg administration

Primary outcome measure

  • Serum Magnesium level [ Time Frame: Through study completion, an average of 1 year ]
  • Magnesium- Pharmakokinetics Clearance (CL) [ Time Frame: Through study completion, an average of 1 year ]
  • Magnesium- Pharmacokinetics central volume of distribution (Vc) [ Time Frame: Through study completion, an average of 1 year ]
  • Magnesium- Pharmakokinetics (PK) intercompartmental clearance (Q) [ Time Frame: Through study completion, an average of 1 year ]
  • Magnesium- Pharmakokinetics peripheral volume of distribution (Vp) [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

University of California San Francisco Hospital

Recruiting

San Francisco, California, United States, 94143

Contacts

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-21.