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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 at 30 minutes, two hours, eight hours, 24 hours after surgery
Awards & highlights

Study Summary

Intra operative Nerve Monitoring ( IONM ) is rapidly becoming the standard of care for thyroid surgery to prevent injury to the recurrent laryngeal nerve. However the laryngo tracheal reflexes need to be adequately suppressed to permit proper utilization of intra operative nerve monitoring. Increasing the depth of anesthesia to achieve this often leads to side effects. Intravenous lidocaine infusion has been shown to be effective in blunting these reflexes. The planned study intends to look at the efficacy of intravenous lidocaine infusion in decreasing the amount of anesthesia medications needed to suppress the reflexes. Also the study looks at the analgesic and anti emetic properties of intravenous lidocaine infusion post operatively by measuring these outcomes. The study is designed as a double blinded randomized controlled trial with 30 subjects in the group who will receive intravenous lidocaine during surgery and 30 subjects in the group who will receive placebo. Blunting of the laryngo tracheal reflexes intra operatively will be recorded as the primary outcome. The amount of anesthesia medications, the post operative patient comfort level, pain control, usage of narcotic pain medications, nausea, vomiting will be recorded as secondary outcomes.

Eligible Conditions
  • Thyroidectomy
  • Nerve Monitoring

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from beginning of surgery to the end of surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and from beginning of surgery to the end of surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Suppression of laryngo tracheal reflexes during thyroid surgery
Secondary outcome measures
Amount of Anesthesia medications used
Post operative nausea
Post operative overall patient comfort as measure of the anti inflammatory effect of Lidocaine
+2 more

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

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
Oregon
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~7 spots leftby May 2025