Recruiting

Magnesium Sulfate

Sponsor:

Loma Linda University

Code:

NCT04938765

Conditions

Intraoperative Neurophysiological Monitoring

Magnesium Sulfate

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Magnesium sulfate

Normal Saline

Study Details

Brief summary:

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.

Conditions

Intraoperative Neurophysiological Monitoring

Magnesium Sulfate

Study ID

NCT04938765

Start date

Mar 18, 2022

Status verified date

Apr, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria.

  • Patients aged 18 to 80 years
  • Belonging to American Society of Anesthesiologists physical status (ASA) I, II
  • Undergoing elective spine or cranial surgery where intraoperative neuromonitoring including short latency somatosensory evoked potentials (SSEP or SEP) and transcranial electrical muscle motor evoked potentials recording from muscles (TceMEP or TcMEP or mMEP or MEP) is planned.

Exclusion Criteria:

  • Magnesium use within the last 2 days, either intravenous or oral supplements.
  • Patients with known electrolyte imbalances (Sodium <135 or >145 mmol/L OR Potassium < 3.5 or > 5.0 mmol/L, Magnesium >1.2 mmol/L.
  • Severe cardiac or cardiac conduction disorders.
  • Severe pulmonary disease.
  • Patients with significant neuromuscular disorders or preexisting motor or sensory deficits other than focal upper limb neuropathy or focal cervical radiculopathy or mild cervical myelopathy.
  • Severe Renal disease - serum creatinine of > 2 mg/dl.
  • Pregnant or breastfeeding patients.
  • Unable to obtain adequate baseline SSEPs and MEPs.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Magnesium sulfate arm

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.

placebo comparator: Normal Saline

20 ml of normal saline bolus will be administered to the control group over 10 mins.

Interventions

Magnesium sulfate

Effect of 40mg/kg Magnesium sulfate bolus dosed to ideal body weight on intraoperative neuromonitoring

Normal Saline

20 ml of normal saline bolus will be administered to the control group over 10 mins.

Primary outcome measure

  • Change in the amplitude of SSEPs. [ Time Frame: Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline. ]

Central Contacts and Locations

Central contacts

Rashmi Vandse, MD

9095584000rvandse@llu.edu

Locations

Loma linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Rashmi Vandse, MD

909-558-4000rvandse@llu.edu

Penelope Garcia

909.558.5966pegarcia@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • multimodal analgesia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-04-24.