Effect of Magnesium on Neuromonitoring

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

Intraoperative neurophysiologic monitoring (IONM) is commonly used during complex spinal surgery to monitor the integrity of neural structures and improve the perioperative safety profile. Transcranial Motor Evoked Potentials (TcMEPs) monitor the integrity of the motor pathways and are one of the most commonly used monitoring modalities in spinal surgery. Because inhaled anesthetics can negatively affect the ability to monitor TcMEPs, anesthesiologists commonly use a combination of propofol and opioids to maintain the anesthetic state. Additionally, anesthesiologists will frequently administer intravenous infusions of medications that can decrease postoperative pain and opioid use (called opioid-sparing adjuncts) because spinal surgeries result in significant postoperative pain. Despite the increasing use of these agents, there is scant clinical data about how they may affect the integrity of TcMEP monitoring. Magnesium (Mg), a N-methyl-d-aspartate receptors (NMDA) receptor antagonist, is one of the adjuncts with robust data supporting clinical efficacy to decrease pain and opioid use on TcMEPs. Mg has been used clinically for decades. The investigators commonly utilize intravenous magnesium as a component of our spinal anesthesia protocol. However, there is only a single case report that discusses the effects of Mg on TcMEPs. Here the investigators propose a prospective clinical trial to quantitatively assess the effects of various Mg plasma levels on TcMEPs. There is a lack of literature on the pharmacokinetics of magnesium in non-pregnant patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Patients with a history of significant cardiac disease (LVEF <35%, 2nd/3rd-degree block without a pacemaker, or significant arrhythmia)

Patients with kidney disease (GFR <30), or hepatic dysfunction (history of cirrhosis)

Allergy or sensitivity to magnesium

Patient with neuromuscular disease such as myasthenia graves

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesium sulfate administration

    Drug

    A single intravenous bolus of Mg of 30mg/kg (based on ideal body weight) will be administered over a period of 10 minutes (min). Control group will not have any Mg administration

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Magnesium ArmExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Serum Magnesium level

Serum magnesium level will be measured by UCSF Lab.

Time frame
Through study completion, an average of 1 year
2

Magnesium- Pharmakokinetics Clearance (CL)

Serum magnesium level will be measured by UCSF Lab. Then the investigators will run the Pharmakokinetics clearance (CL) data with the levels.

Time frame
Through study completion, an average of 1 year
3

Magnesium- Pharmacokinetics central volume of distribution (Vc)

Serum magnesium level will be measured by UCSF Lab. Then the investigators will run the Pharmacokinetics Central volume of distribution (Vc) data with the levels.

Time frame
Through study completion, an average of 1 year
4

Magnesium- Pharmakokinetics (PK) intercompartmental clearance (Q)

Serum magnesium level will be measured by UCSF Lab. Then the investigators will run the PK intercompartmental clearance (Q) data with the levels.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

Neuromonitoring data-Stimulation voltage

The investigators will change in stimulation voltage in different time points using the students t-test

Time frame
Through study completion, an average of 1 year
2

Neuromonitoring data- motor-evoked potential (MEP) amplitude

The investigators will compare motor-evoked potential (MEP) amplitude responses at different time points using the students t-test.

Time frame
Through study completion, an average of 1 year
3

Neuromonitoring data- Motor Evoked Potential (MEP) Latency

The investigators will compare the change in MEP latency using the students t-test

Time frame
Through study completion, an average of 1 year

Other outcomes

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