Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

August 18, 2023 updated by: Loma Linda University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to investigate the effect of magnesium sulfate on the amplitude of the SSEP with tibial nerve stimulation. Secondary objectives are to study the effect of magnesium sulfate on the latency of SSEPs and the amplitude of MEPs in patients undergoing spine and/or cranial surgery requiring intraoperative neuromonitoring.

Background: Magnesium Sulfate is increasingly being used as part of the multimodal pain regimen in the perioperative period. The efficacy of intravenous (IV) magnesium sulfate in reducing the postoperative pain scores and/or postoperative opioid use has been established in several randomized controlled trials, systematic reviews, and meta-analyses. The multimodal intraoperative neurophysiological monitoring (IONM) is increasingly being utilized in complex spine surgeries to assess the functional integrity of the neural pathways. The goal of IONM is to avert permanent damage by proving real-time feedback from sensory tracts, motor tracts, and individual nerve roots thus alerting any impending injury which allows for modification of management in time.

Several factors like, hypoxia, hypercarbia, changes in blood pressure and temperature can affect the IONM in addition to direct surgical injury to neural structures. In addition, several drugs including anesthetic agents can have a significant effect on IONM. Hence anesthetic regimen is usually tailored to facilitate IONM during these surgeries. The infusion of propofol and remifentanil are commonly used for maintenance of anesthesia during these procedures. Opioid analgesics play a central role in the anesthetic cocktail as the pain associated with complex spinal surgery can be debilitating. However, opioids can also complicate the postoperative pain management by inducing opioid induced hyperalgesia and /or tolerance. The current trend is to implement a multimodal analgesic approach to achieve an additive or synergistic analgesic effect by targeting different receptors in the peripheral and central pain signaling pathways while minimizing opioid-related adverse effects. Magnesium sulfate has shown promising results when used as part of the multimodal pain management in previous studies in addition it can also has shown to attenuate the remifentanil-induced hyperalgesia which is commonly used as part of the anesthetic regimen. However, the effect of Magnesium Sulfate on intraoperative neuromonitoring is not been studied.

Methods Procedures involved (Research Interventions):

After obtaining the written informed consent and premedication, patients will be taken to the operating room. The standard ASA monitors will be applied. They will be monitored with electrocardiography, noninvasive and/or invasive blood pressure (BP), pulse oximetry, and temperature monitor along with brain function monitor to monitor the depth of anesthesia (Sedline monitor) during surgery.

After preoxygenation, the patient will be induced with general anesthesia using fentanyl 1-3 mg/kg or Remifentanil 1-3 mcg/kg, lidocaine 1-2 mg/kg, Propofol 1-3 mg/kg, and succinylcholine 1-2 mg/kg or Rocuronium 0.3-0.5 mg/kg. Inhalation anesthetic agents will not be used for induction or maintenance of anesthesia but may be used after the end of data collection for this study and/or during closing. Anesthetic infusion consisting of propofol 50-150 mg/kg, remifentanil 0.05-0.2 mg/kg will be started immediately after the induction for maintenance of general anesthesia and doses may be adjusted to higher amounts if needed. The BP will be maintained within 20% of patient's baseline using phenylephrine infusion or other appropriate vasoactive agents after the induction of anesthesia. End-tidal carbon dioxide will be maintained within normal limits. Patients will be actively warmed using a Bair Hugger™ or similar device(s) ("warmer(s)") to prevent any hypothermia.

In patients given rocuronium, neuromuscular blockage will be reversed before obtaining the baseline IONM recordings. The baseline set of SSEPs and MEPs will be recorded before the study drug administration and consisting of 2 to 4 measurements; T0 represents the average of these measurements. For study group, MgSo4 diluted to < 20% concentration in 20 ml normal saline will be administered as 40 mg/kg bolus dosed to ideal body weight over 10 min. For control group, 20 ml of normal saline bolus will be administered over 10 mins. Magnesium group will also be given continuous infusion of MgSO4 at 10mg/kg/hr. till the end of the surgery. Repeat SSEPs and MEPs will be recorded at the end of the bolus ("0" minutes) (T1) as well as 10 (T2) and 30 (T3) minutes following the completion of the bolus dose.

Patient's hemodynamic data also will be collected at baseline and every 5 mins up to 30 mins following the administration of the drug.

The T1,T2,T3 data will be compared with the To(baseline) data to evaluate the effect of MgSO4 on intraoperative neuromonitoring.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
          • Rashmi Vandse, MD
          • Phone Number: 88054 909-558-4000
          • Email: rvandse@llu.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria.

  • 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.

Exclusion Criteria:

  • 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.
  • Patients with significant neuromuscular disorders or preexisting motor or sensory deficits other than focal upper limb neuropathy or focal cervical radiculopathy or mild cervical myelopathy.
  • Severe Renal disease - serum creatinine of > 2 mg/dl.
  • Pregnant or breastfeeding patients.
  • Unable to obtain adequate baseline SSEPs and MEPs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium sulfate arm
MgSo4 diluted to 20% will be administered at 40 mg/kg dosed to ideal body weight over 10min to the study arm followed by 10mg/kg/hr infusion.
Drug: Magnesium sulfate
Effect of 40mg/kg Magnesium sulfate bolus dosed to ideal body weight on intraoperative neuromonitoring
Placebo Comparator: Normal Saline
20 ml of normal saline bolus will be administered to the control group over 10 mins.
Drug: Normal Saline
20 ml of normal saline bolus will be administered to the control group over 10 mins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the amplitude of SSEPs.
Time Frame: 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.
Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the latency of SSEP compared to baseline.
Time Frame: 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.10% increase in latency will be considered as significant change.
Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.
Change in the amplitude of MEPs.
Time Frame: Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.
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
Up to 30 minutes after the end of bolus dose of MgSO4 or Normal saline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Principal Investigator: Rashmi Vandse, MD, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 18, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5210244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Magnesium Sulfate

Clinical Trials on Magnesium sulfate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe