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Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

ConditionsIntraoperative Neurophysiological MonitoringMagnesium Sulfate
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLoma Linda University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 to 80 years

Belonging to American Society of Anesthesiologists physical status (ASA) I, II

Undergoing elective spine or cranial surgery where intraoperative neuromonitoring including short latency somatosensory evoked potentials (SSEP or SEP) and transcranial electrical muscle motor evoked potentials recording from muscles (TceMEP or TcMEP or mMEP or MEP) is planned.

Disqualifiers

Magnesium use within the last 2 days, either intravenous or oral supplements.

Patients with known electrolyte imbalances (Sodium <135 or >145 mmol/L OR Potassium < 3.5 or > 5.0 mmol/L, Magnesium >1.2 mmol/L.

Severe cardiac or cardiac conduction disorders.

Severe pulmonary disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Magnesium sulfate armExperimental treatment 1 intervention
Group B: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in the amplitude of SSEPs.

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.

Time frame
Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.

Secondary outcomes

1

Change in the latency of SSEP compared to baseline.

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.10% increase in latency will be considered as significant change.

Time frame
Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.
2

Change in the amplitude of MEPs.

Baseline MEP recording is done before the administration of MgSo4 or placebo and will be compared with the MEPs measured at 0, 10 and 30 minutes following the end of the bolus dose of MgSO4 or normal saline. Any change in the amplitude of MEPs will be analyzed .For MEPs, 75% decrease in amplitude is considered as significant change

Time frame
Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loma Linda University

Lead sponsor

Source ClinicalTrials.gov
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