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Efficacy of Intravenous Lidocaine in the Operative Management of Thyroid Surgery With Intraoperative Nerve Monitoring
Phase 4
Waitlist Available
Led By Ramasamy Govindarajan, MD
Research Sponsored by Bronx-Lebanon Hospital Center Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from beginning of surgery to the end of surgery
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
Pivotal Trial
Summary
This trial tests if giving lidocaine through an IV can help patients having thyroid surgery by reducing throat reflexes, pain, and nausea. It aims to make nerve monitoring during surgery safer and more effective. Lidocaine is a local anesthetic used to relieve various types of pain.
Eligible Conditions
- Nerve Monitoring
- Thyroidectomy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 hours of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 hours of surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Suppression of laryngo tracheal reflexes during thyroid surgery
Secondary study objectives
Amount of Anesthesia medications used
Post operative nausea
Post operative overall patient comfort as measure of the anti inflammatory effect of Lidocaine
+2 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LidocaineExperimental Treatment1 Intervention
Subjects in the Lidocaine arm of the randomized trial will receive a bolus of 1 mg /Kg of IV lidocaine followed by 1.5 mg/KG/h of IV lidocaine infusion during the surgery which will be stopped at extubation.
Group II: PlaceboPlacebo Group1 Intervention
Subjects in the Placebo arm of the randomized trial will receive a bolus of 1mg/kg Placebo ( 0.9% saline) followed by 1.5 mg/KG/h Placebo ( 0.9% saline) infusion during the surgery which will be stopped at extubation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved
Find a Location
Who is running the clinical trial?
Bronx-Lebanon Hospital Center Health Care SystemLead Sponsor
7 Previous Clinical Trials
1,499 Total Patients Enrolled
Ramasamy Govindarajan, MDPrincipal InvestigatorBronx Lebanon Hospital Center