Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

Part of paid clinical trials in Loma Linda, California.

Sponsor
Loma Linda University
Study ID
NCT04938765
Phase
PHASE4
Status
Recruiting

Conditions

  • Intraoperative Neurophysiological Monitoring
  • Magnesium Sulfate

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnesium sulfate — DRUG
    Effect of 40mg/kg Magnesium sulfate bolus dosed to ideal body weight on intraoperative neuromonitoring
  • Normal Saline — DRUG
    20 ml of normal saline bolus will be administered to the control group over 10 mins.

Study Details

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.

Key Dates

Start date
Mar 18, 2022
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Loma linda University Medical CenterLoma LindaCalifornia92354
Rashmi Vandse, MD
909-558-4000
Penelope Garcia
909.558.5966

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