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

Primary Purpose

Thyroid Cancer, Neck Cancer, Recurrent Laryngeal Nerve Injuries

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lidocaine
Sponsored by
Bo Wang,MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fujian Medical University Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional surgery group

Lidocaine group

Arm Description

Induction of anesthesia according to conventional neuromuscular blockade dose, no neuromuscular blockade drug maintenance during lateral neck dissection.

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.

Outcomes

Primary Outcome Measures

dose of muscle relaxant drugs
dose of muscle relaxant drugs
dose of lidocaine
dose of lidocaine
Number of nerve signal loss cases
Number of nerve signal loss cases
Anatomical time of accessory nerve
Anatomical time of accessory nerve
The satisfaction of sternocleidomastoid muscle separation
The visual score was 5 points for the most satisfaction and 0 points for the most dissatisfied.

Secondary Outcome Measures

Full Information

First Posted
May 8, 2018
Last Updated
September 17, 2018
Sponsor
Bo Wang,MD
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1. Study Identification

Unique Protocol Identification Number
NCT03530033
Brief Title
Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bo Wang,MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Neck Cancer, Recurrent Laryngeal Nerve Injuries, Accessory Nerve Injuries, EMG: Repetitive Nerve Stimulation Abnormality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional surgery group
Arm Type
No Intervention
Arm Description
Induction of anesthesia according to conventional neuromuscular blockade dose, no neuromuscular blockade drug maintenance during lateral neck dissection.
Arm Title
Lidocaine group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Local injection of lidocaine reduces muscle tremor
Primary Outcome Measure Information:
Title
dose of muscle relaxant drugs
Description
dose of muscle relaxant drugs
Time Frame
At the end of surgery
Title
dose of lidocaine
Description
dose of lidocaine
Time Frame
At the end of surgery
Title
Number of nerve signal loss cases
Description
Number of nerve signal loss cases
Time Frame
At the end of surgery
Title
Anatomical time of accessory nerve
Description
Anatomical time of accessory nerve
Time Frame
At the end of surgery
Title
The satisfaction of sternocleidomastoid muscle separation
Description
The visual score was 5 points for the most satisfaction and 0 points for the most dissatisfied.
Time Frame
At the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn
Facility Information:
Facility Name
Fujian Medical University Union Hospital
City
FuZhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
bo wang, md
Phone
13705947900
Email
wangbo@fjmu.edu.cn

12. IPD Sharing Statement

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

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