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

NCT ID: NCT03530033

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-10-31

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.

Conditions

Thyroid Cancer; Neck Cancer; Recurrent Laryngeal Nerve Injuries; Accessory Nerve Injuries; EMG: Repetitive Nerve Stimulation Abnormality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional surgery group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Local injection of lidocaine reduces muscle tremor

Interventions

Lidocaine

Local injection of lidocaine reduces muscle tremor

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bo Wang,MD

OTHER

Sponsor Role: lead

Responsible Party

Bo Wang,MD

clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

bo wang, md

Role: CONTACT

wangbo@fjmu.edu.cn

13705947900

Facility Contacts

bo wang, md

Role: primary

wangbo@fjmu.edu.cn

13705947900

Other Identifiers

BND IONM Lidocaine

Identifier Type: -

Identifier Source: org_study_id