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

September 17, 2018 updated by: Bo Wang,MD

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • FuZhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conventional surgery group
Induction of anesthesia according to conventional neuromuscular blockade dose, no neuromuscular blockade drug maintenance during lateral neck dissection.
Experimental: Lidocaine group
Anesthesia induction was performed according to conventional nerve monitoring neuromuscular blockade doses and lateral neck dissection was performed. When local muscle tremors occur, lidocaine is injected locally to eliminate muscle tremors.
Drug: Lidocaine
Local injection of lidocaine reduces muscle tremor

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bo Wang,MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Anticipated)

October 31, 2018

Study Completion (Anticipated)

October 31, 2018

Study Registration Dates

First Submitted

May 8, 2018

First Submitted That Met QC Criteria

May 17, 2018

First Posted (Actual)

May 21, 2018

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 17, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BND IONM Lidocaine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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