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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02479789
Other study ID # 04091501
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received June 21, 2015
Last updated February 19, 2018
Start date June 2015
Est. completion date July 2018

Study information

Verified date February 2018
Source Bronx-Lebanon Hospital Center Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine

Placebo


Locations

Country Name City State
United States Health and Wellness Center- Bronx Lebanon Hospital Center Bronx New York

Sponsors (1)

Lead Sponsor Collaborator
Bronx-Lebanon Hospital Center Health Care System

Country where clinical trial is conducted

United States, 

References & Publications (1)

Govindarajan R, Shah A, Reddy VS, Parithivel V, Ravikumar S, Livingstone D. Improving the functionality of intra-operative nerve monitoring during thyroid surgery: is lidocaine an option? J Clin Med Res. 2015 Apr;7(4):282-5. doi: 10.14740/jocmr2025w. Epub — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Suppression of laryngo tracheal reflexes during thyroid surgery Number of times laryngo tracheal reflexes were encountered during surgery will be recorded. From beginning of surgery to the end of surgery
Secondary Amount of Anesthesia medications used The total amount of each anesthesia medication used will be recorded From beginning of surgery to the end of surgery
Secondary Post operative pain control Pain will be measured on a scale of 1 to 10 At 30 minutes, two hours, eight hours, 24 hours after surgery
Secondary Post operative usage of medications to control pain The total amount of medications used to control pain will be recorded Within 24 hours of surgery
Secondary Post operative nausea Number of episodes of nausea and vomiting will be recorded At 30 minutes, two hours, eight hours, 24 hours after surgery
Secondary Post operative overall patient comfort as measure of the anti inflammatory effect of Lidocaine Comfort level will be measured on a scale of 1 to 10 At 30 minutes, two hours, eight hours, 24 hours after surgery
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