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NCT04938765 · ClinicalTrials.gov registry record · Phase 4
Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring
A Phase 4 study of Intraoperative Neurophysiological Monitoring and Magnesium Sulfate, sponsored by Loma Linda University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04938765: Recruiting Phase 4 study of Intraoperative Neurophysiological Monitoring and Magnesium Sulfate, sponsored by Loma Linda University.
NCT04938765 is a Phase 4 study of Intraoperative Neurophysiological Monitoring and Magnesium Sulfate that is actively recruiting participants, run by Loma Linda University. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04938765, a Phase 4 study of Intraoperative Neurophysiological Monitoring and Magnesium Sulfate, is actively recruiting participants, sponsored by Loma Linda University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Magnesium sulfate
- DRUG Normal Saline
Study Locations (1)
California
- Loma linda University Medical Center - Loma Linda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-03-18 |
| Est. Completion | 2026-03 |
| Phase | Phase 4 |
What NCT04938765 shows while recruiting
NCT04938765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Intraoperative Neurophysiological Monitoring appearing as the primary indexed condition, and to 2 interventions - of which Magnesium sulfate is the first listed.
NCT04938765 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04938765 about?
NCT04938765 is a clinical study titled "Effect of Magnesium Sulfate Bolus 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 ...
What is the current status of trial NCT04938765?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2022-03-18. Estimated completion is 2026-03.
What conditions does trial NCT04938765 study?
This clinical trial studies the following conditions: Intraoperative Neurophysiological Monitoring, Magnesium Sulfate.
What interventions are being tested in trial NCT04938765?
The interventions under investigation include: Magnesium sulfate (DRUG), Normal Saline (DRUG).
Who is sponsoring clinical trial NCT04938765?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04938765 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04938765's enrollment target sits among peer trials
50 1255th of 2000 higher than 679 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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