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Magnesium Sulfate for Intraoperative Neuromonitoring

Phase 4
Recruiting
Led By Rashmi Vandse, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 18 to 80 years
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 minutes after the end of bolus dose of mgso4 or normal saline.
Awards & highlights

Study Summary

This trial will help determine if magnesium sulfate has any effect on IONM readings during surgery.

Who is the study for?
This trial is for adults aged 18-80, with good to moderate health (ASA I or II), undergoing elective spine or cranial surgery where monitoring of nerve function is planned. It's not for those with electrolyte imbalances, severe lung or kidney disease, pregnant/breastfeeding women, inadequate baseline nerve signals, heart disorders, recent magnesium use, or significant neuromuscular issues.Check my eligibility
What is being tested?
The study tests the effect of a Magnesium sulfate bolus on intraoperative neurophysiological monitoring signals during surgery. Patients are randomly assigned to receive either Magnesium sulfate or a placebo (Normal Saline) in a double-blind manner to compare changes in nerve signal strength and speed.See study design
What are the potential side effects?
Potential side effects from Magnesium sulfate may include flushing, sweating, lowered blood pressure, confusion, muscle weakness and slowed breathing. Normal Saline typically has no side effects but can cause vein irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am scheduled for spine or brain surgery with specific nerve function monitoring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 minutes after the end of bolus dose of mgso4 or normal saline.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 minutes after the end of bolus dose of mgso4 or normal saline. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the amplitude of SSEPs.
Secondary outcome measures
Change in the amplitude of MEPs.
Change in the latency of SSEP compared to baseline.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium sulfate armExperimental Treatment1 Intervention
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.
Group II: Normal SalinePlacebo Group1 Intervention
20 ml of normal saline bolus will be administered to the control group over 10 mins.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnesium sulfate
2018
Completed Phase 4
~1630

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,934 Total Patients Enrolled
Rashmi Vandse, MDPrincipal InvestigatorLoma Linda University

Media Library

Magnesium sulfate Clinical Trial Eligibility Overview. Trial Name: NCT04938765 — Phase 4
Intraoperative Neurophysiological Monitoring Research Study Groups: Magnesium sulfate arm, Normal Saline
Intraoperative Neurophysiological Monitoring Clinical Trial 2023: Magnesium sulfate Highlights & Side Effects. Trial Name: NCT04938765 — Phase 4
Magnesium sulfate 2023 Treatment Timeline for Medical Study. Trial Name: NCT04938765 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~0 spots leftby Jun 2024