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Randomized and Placebo Controlled Study to Evaluate the Effect of Magnesium Sulfate on Intraoperative Neuromonitoring.
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.
Details
| Lead sponsor | Loma Linda University |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 50 |
| Start date | 2022-03-18 |
| Completion | 2027-03 |
Conditions
- Intraoperative Neurophysiological Monitoring
- Magnesium Sulfate
Interventions
- Magnesium sulfate
- Normal Saline
Primary outcomes
- Change in the amplitude of SSEPs. — Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.
Baseline SSEP recording is done before the administration of MgSo4 or placebo and will be compared with the SSEPs measured at 0,10 and 30 minutes following the end of the bolus dose of MgSO4 or normal saline. Any change in the amplitude will be analyzed. For SSEPs, 50% reduction in amplitude will be considered as significant change.
Countries
United States