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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479789
Recruitment Status : Unknown
Verified February 2018 by Ramasamy Govindarajan, Bronx-Lebanon Hospital Center Health Care System.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2015
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Ramasamy Govindarajan, Bronx-Lebanon Hospital Center Health Care System

Brief 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.


Condition or disease Intervention/treatment Phase
Thyroidectomy Nerve Monitoring Drug: Lidocaine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy of Intravenous Lidocaine in the Operative Management of Thyroid Surgery With Intraoperative Nerve Monitoring
Study Start Date : June 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Diseases

Arm Intervention/treatment
Experimental: Lidocaine
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.
Drug: Lidocaine
Other Name: Xylocaine, Lignocaine

Placebo Comparator: Placebo
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.
Drug: Placebo
Other Name: Normal Saline




Primary Outcome Measures :
  1. Suppression of laryngo tracheal reflexes during thyroid surgery [ Time Frame: From beginning of surgery to the end of surgery ]
    Number of times laryngo tracheal reflexes were encountered during surgery will be recorded.


Secondary Outcome Measures :
  1. Amount of Anesthesia medications used [ Time Frame: From beginning of surgery to the end of surgery ]
    The total amount of each anesthesia medication used will be recorded

  2. Post operative pain control [ Time Frame: At 30 minutes, two hours, eight hours, 24 hours after surgery ]
    Pain will be measured on a scale of 1 to 10

  3. Post operative usage of medications to control pain [ Time Frame: Within 24 hours of surgery ]
    The total amount of medications used to control pain will be recorded

  4. Post operative nausea [ Time Frame: At 30 minutes, two hours, eight hours, 24 hours after surgery ]
    Number of episodes of nausea and vomiting will be recorded

  5. Post operative overall patient comfort as measure of the anti inflammatory effect of Lidocaine [ Time Frame: At 30 minutes, two hours, eight hours, 24 hours after surgery ]
    Comfort level will be measured on a scale of 1 to 10



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consenting patients undergoing bilateral thyroid surgery
  • Age- 18-85 y

Exclusion Criteria:

  • Patients undergoing additional procedures,
  • Patients younger than 18y or older than 85 years.
  • Patients at high risk for use of lidocaine due to Congestive heart failure, arrhythmia.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479789


Locations
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United States, New York
Health and Wellness Center- Bronx Lebanon Hospital Center
Bronx, New York, United States, 10457
Sponsors and Collaborators
Bronx-Lebanon Hospital Center Health Care System
Investigators
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Principal Investigator: Ramasamy Govindarajan, MD Bronx Lebanon Hospital Center

Publications of Results:
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Responsible Party: Ramasamy Govindarajan, Clinical Research In-Charge, Anesthesia, Bronx-Lebanon Hospital Center Health Care System
ClinicalTrials.gov Identifier: NCT02479789    
Other Study ID Numbers: 04091501
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study still recruiting
Keywords provided by Ramasamy Govindarajan, Bronx-Lebanon Hospital Center Health Care System:
Intravenous Lidocaine
Recurrent laryngeal nerve
Intra operative nerve monitoring
Thyroidectomy
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action