Thyroidectomy Clinical Trial
Official title:
Efficacy of Intravenous Lidocaine in the Operative Management of Thyroid Surgery With Intraoperative Nerve Monitoring
Verified date | February 2018 |
Source | Bronx-Lebanon Hospital Center Health Care System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 66 |
Est. completion date | July 2018 |
Est. primary completion date | July 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Health and Wellness Center- Bronx Lebanon Hospital Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Bronx-Lebanon Hospital Center Health Care System |
United States,
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
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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