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 — DRUGEffect of 40mg/kg Magnesium sulfate bolus dosed to ideal body weight on intraoperative neuromonitoring
- Normal Saline — DRUG20 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 armMgSo4 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 Saline20 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
- Rashmi Vandse, MD9095584000
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Loma linda University Medical Center | Loma Linda | California | 92354 |