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Status unknownNCT03530033Updated Sep 18, 2018

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

An interventional study of Lidocaine in Thyroid Cancer, Neck Cancer and Recurrent Laryngeal Nerve Injuries, sponsored by Bo Wang,MD. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by Bo Wang,MD · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Thyroid Cancer
  • Neck Cancer
  • Recurrent Laryngeal Nerve Injuries
  • Accessory Nerve Injuries
  • EMG: Repetitive Nerve Stimulation Abnormality
03

In context

Thyroid Neoplasms

785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.

This study's planned enrollment of 40 is below the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.

Browse Thyroid Neoplasms studies →

Lead sponsor

Bo Wang,MD is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Lidocaine allergy sufferers
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

Interventions

  • Local injection of lidocaine reduces muscle tremor

06

What researchers measure

Primary outcomes

  1. dose of muscle relaxant drugs

    dose of muscle relaxant drugs

    Time frame: At the end of surgery

  2. dose of lidocaine

    dose of lidocaine

    Time frame: At the end of surgery

  3. Number of nerve signal loss cases

    Number of nerve signal loss cases

    Time frame: At the end of surgery

  4. Anatomical time of accessory nerve

    Anatomical time of accessory nerve

    Time frame: At the end of surgery

  5. The satisfaction of sternocleidomastoid muscle separation

    The visual score was 5 points for the most satisfaction and 0 points for the most dissatisfied.

    Time frame: At the end of surgery

07

Study locations

1 of 1 sites recruiting
  • Fujian Medical University Union Hospital
    FuZhou, Fujian 350001, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03530033
Lead sponsor
Bo Wang,MD
Responsible party
Bo Wang,MD (clinical Professor, Fujian Medical University) — Sponsor-investigator
First posted
May 21, 2018
Start date
May 1, 2018
Primary completion
Oct 31, 2018 (estimated)
Completion
Oct 31, 2018 (estimated)
Last update
Sep 18, 2018

Study contacts

bo wang, md
Contact
wangbo@fjmu.edu.cn
13705947900

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Lidocaine

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