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Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary and study completion dates: Mar 2026 to Mar 2027v9
  2. Minor Primary and study completion dates: Dec 2025 to Mar 2026v8
  3. Notable Primary and study completion dates: Jun 2024 to Dec 2025v7
  4. Notable Primary and study completion dates: Jun 2023 to Jun 2024v6
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2022 to Mar 18, 2022
    • Study site revised
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: Dec 2021 to Jun 2022
    • Primary and study completion dates: Dec 2022 to Jun 2023
    v4
  2. Notable Start date: Oct 2021 to Dec 2021v3 Show 4 more changesShow less
    • Primary endpoints: 2 to 1
    • Secondary endpoints: 1 to 2
    • Study description expanded, about 108 words
    • Eligibility criteria shortened, about 2 words
  3. Notable Start date: Jul 2021 to Oct 2021v2 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Eligibility criteria revised
    • Secondary endpoint revised
    • Study title expanded, about 2 words
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04938765
Lead Sponsor Loma Linda University
Conditions
(from sponsor)
Intraoperative Neurophysiological Monitoring, Magnesium Sulfate
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov