Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring

Thyroid Cancer Clinical Trial

Official title:

Lidocaine Reduces Muscle Tremor Caused by Electric Energy Devices, Which is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring During Endoscopic Thyroid Lateral Neck Dissection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03530033
• Other study ID #: BND IONM Lidocaine
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: September 2018
• Source: Fujian Medical University
• Contact: bo wang, md
• Phone: 13705947900
• Email: wangbo[@]fjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In recent years, the application of intraoperative recurrent laryngeal nerve monitoring in thyroid surgery has greatly reduced the complications of recurrent laryngeal nerve injury. The use of intraoperative neurological monitoring requires the reduction of the dose of neuromuscular blockade, which often leads to muscle tremors during the application of electrical energy, which affects the fine separation around the muscles. This study explored the effect of local application of lidocaine on reducing muscle tremor during surgery and its optimal dose.

Description:

According to the random number method, eligible patients were randomly divided into 2 groups. Group A was the conventional surgery group, and Group B was the lidocaine group. The operative time for the separation of the sternocleidomastoid muscle from the two groups of patients was analyzed, as well as the length of time for the search for the accessory nerve and the effect of intraoperative nerve monitoring on the EMG signal.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Thyroid papillary carcinoma

• Lateral cervical lymph node metastasis

• The diameter of the metastatic lymph nodes is less than 3cm

• Without internal jugular vein invasion

Exclusion Criteria:

• Lidocaine allergy sufferers

Related Conditions & MeSH terms

• Accessory Nerve Injuries
• EMG: Repetitive Nerve Stimulation Abnormality
• Neck Cancer
• Recurrent Laryngeal Nerve Injuries
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms
• Tremor
• Wounds and Injuries

Intervention

Drug:
• Lidocaine
Local injection of lidocaine reduces muscle tremor

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	FuZhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Bo Wang,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose of muscle relaxant drugs	dose of muscle relaxant drugs	At the end of surgery
Primary	dose of lidocaine	dose of lidocaine	At the end of surgery
Primary	Number of nerve signal loss cases	Number of nerve signal loss cases	At the end of surgery
Primary	Anatomical time of accessory nerve	Anatomical time of accessory nerve	At the end of surgery
Primary	The satisfaction of sternocleidomastoid muscle separation	The visual score was 5 points for the most satisfaction and 0 points for the most dissatisfied.	At the end of surgery