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Magnesium Sulfate for Intraoperative Neuromonitoring
Study Summary
This trial will help determine if magnesium sulfate has any effect on IONM readings during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am between 18 and 80 years old.My kidney function is poor, with a creatinine level over 2 mg/dl.I do not have severe heart or rhythm problems.I have severe lung disease.I have no major nerve or muscle disorders, except for some specific nerve issues in my arm or neck.I am scheduled for spine or brain surgery with specific nerve function monitoring.I have taken magnesium, either by mouth or IV, in the last 2 days.
- Group 1: Magnesium sulfate arm
- Group 2: Normal Saline
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What are the potential hazards of Magnesium sulfate usage in medical treatments?
"There is a wealth of clinical data supporting Magnesium sulfate's safety, thus it was granted an impressive rating of 3."
Is the age range for this trial inclusive of individuals over 40?
"Patients must be older than 18 years yet younger than 80 to qualify for this medical trial."
Are there any current openings for participation in this research?
"Correct. The online registry of clinicaltrials.gov affirms that this medical investigation is presently enrolling patients; it was initially posted on March 18th 2022 and most recently updated on July 7th 2022. It requires 50 participants to be sourced from 2 distinct sites."
How many participants are actively involved in this medical experiment?
"Affirmative. As evidenced on the clinicaltrials.gov website, this medical trial is still open for enrollment and began recruiting patients in March of 2022; the data was last updated on July 7th. Fifty participants will be accepted at two different sites."
Am I eligible to join this clinical trial?
"This medical study seeks 50 candidates aged 18-80 years who are undergoing elective spine or cranial surgery with the intention of using intraoperative neuromonitoring including SSEP and TcMEP."
Has Magnesium sulfate been used previously in any other medical experimentation?
"Presently, 27 clinical trials that involve the use of Magnesium sulfate are active with 8 in their final stage. While most sites for this research are in Guangzhou, Guangdong Province, there are 42 overall locations running trials on Magnesium sulphate."
In what instances is Magnesium sulfate typically administered?
"Magnesium sulfate is a common remedy for hypomagnesemia, but also has applications in cases of poisoning, prophylactic low magnesium levels, and contusions."
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