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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 belowSelect...
I am between 18 and 80 years old.
Select...
I am scheduled for spine or brain surgery with specific nerve function monitoring.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 minutes after the end of bolus dose of mgso4 or normal saline.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 minutes after the end of bolus dose of mgso4 or normal saline.
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
260,919 Total Patients Enrolled
Rashmi Vandse, MDPrincipal InvestigatorLoma Linda University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Magnesium sulfate arm
- Group 2: Normal Saline
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- 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.
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