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

NCT03530033 | Unknown

• 1 other identifier: BND IONM Lidocaine
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• dose of muscle relaxant drugs

  dose of muscle relaxant drugs

  At the end of surgery

• dose of lidocaine

  dose of lidocaine

  At the end of surgery

• Number of nerve signal loss cases

  Number of nerve signal loss cases

  At the end of surgery

• Anatomical time of accessory nerve

  Anatomical time of accessory nerve

  At the end of surgery

• 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

Study Arms (2)

Conventional surgery group

NO INTERVENTION

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

Lidocaine group

EXPERIMENTAL

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

Interventions

Lidocaine DRUG

Local injection of lidocaine reduces muscle tremor

Lidocaine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Thyroid papillary carcinoma
• Lateral cervical lymph node metastasis
• The diameter of the metastatic lymph nodes is less than 3cm
• Without internal jugular vein invasion

You may not qualify if:

• Lidocaine allergy sufferers

Sponsors & Collaborators

• Bo Wang,MD: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms; Head and Neck Neoplasms; Recurrent Laryngeal Nerve Injuries; Accessory Nerve Injuries

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Endocrine System Diseases; Thyroid Diseases; Laryngeal Nerve Injuries; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Accessory Nerve Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

bo wang, md

CONTACT

13705947900; wangbo@fjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical Professor

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: May 21, 2018
• Study Start: May 1, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Locations

CN (1)