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Lidocaine for Thyroidectomy

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 24 hours of surgery for reporting.

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 more

Awards & 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

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