RECRUITING

Effect of Magnesium Sulfate Bolus on Intraoperative Neuromonitoring

Talk to us

Conditions

Intraoperative Neurophysiological MonitoringMagnesium Sulfatemultimodal analgesia

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Randomized and Placebo Controlled Study to Evaluate the Effect of Magnesium Sulfate on Intraoperative Neuromonitoring.

Quick Facts

Study Start:2022-03-18
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04938765

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Magnesium use within the last 2 days, either intravenous or oral supplements.
  2. * 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.
  3. * Severe cardiac or cardiac conduction disorders.
  4. * Severe pulmonary disease.
  5. * 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.
  6. * Severe Renal disease - serum creatinine of \> 2 mg/dl.
  7. * Pregnant or breastfeeding patients.
  8. * Unable to obtain adequate baseline SSEPs and MEPs.

Contacts and Locations

Study Contact

Rashmi Vandse, MD
CONTACT
9095584000
rvandse@llu.edu

Principal Investigator

Rashmi Vandse, MD
PRINCIPAL_INVESTIGATOR
Loma Linda University

Study Locations (Sites)

Loma linda University Medical Center
Loma Linda, California, 92354
United States

Collaborators and Investigators

Sponsor: Loma Linda University

  • Rashmi Vandse, MD, PRINCIPAL_INVESTIGATOR, Loma Linda University

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 Registration Dates

Study Start Date2022-03-18
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-03-18
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • multimodal analgesia

Additional Relevant MeSH Terms

  • Intraoperative Neurophysiological Monitoring
  • Magnesium Sulfate