Efficacy of Intravenous Lidocaine in the Operative Management of Thyroid Surgery With Intraoperative Nerve Monitoring
Status unconfirmed · Phase 4 · Has a placebo group
Conditions studied: Thyroidectomy, Nerve Monitoring
In brief
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.
Key facts
- Study ID
- NCT02479789
- Run by
- Bronx-Lebanon Hospital Center Health Care System
- People needed
- 66
- Starts
- 2015-06-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2018-02-22
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Consenting patients undergoing bilateral thyroid surgery
- Age- 18-85 y
You may not qualify if…
- 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.
Where it is running
- Health and Wellness Center- Bronx Lebanon Hospital Center — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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