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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|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|
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.
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.
Other Name: Normal Saline
- 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.
- 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
- 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
- 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
- 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
- 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
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
|United States, New York|
|Health and Wellness Center- Bronx Lebanon Hospital Center|
|Bronx, New York, United States, 10457|
|Principal Investigator:||Ramasamy Govindarajan, MD||Bronx Lebanon Hospital Center|