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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03530033
Other study ID # BND IONM Lidocaine
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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