Efficacy of Intravenous Lidocaine in the Operative Management of Thyroid Surgery With Intraoperative Nerve Monitoring

Description

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.

Study Start Date

June 2015

Estimated Completion Date

December 2016

Interventions

  • Drug: Placebo
  • Drug: Lidocaine

Specialties

  • Surgery: Endocrine
  • Endocrinology: Thyroid/Parathyroid
  • Anesthesiology: Perianesthesia Monitoring,Pharmacology/kinetics

MeSH Terms

  • Anesthetics
  • Central Nervous System Depressants
  • Lidocaine

Study ID

Bronx-Lebanon Hospital Center Health Care System -- 04091501

Status

Unknown

Trial ID

NCT02479789

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

60

Sponsor

Bronx-Lebanon Hospital Center Health Care System

Inclusion Criteria

  • Consenting patients undergoing bilateral thyroid surgery
  • Age
  • 18-80 y

Exclusion Criteria

  • Patients undergoing additional procedures,
  • Patients younger than 18y or older than 80 years.
  • Patients at high risk for use of lidocaine due to Congestive heart failure, arrhythmia.

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Health and Wellness Center Bronx Lebanon Hospital Center - Bronx, New York 42.6 miles Ajay Shah MD FACS 347-820-1560 ajashah@bronxleb.org

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.