Thyroid CancerNCT03530033
Lidocaine Reduces Muscle Tremor is Beneficial for Intraoperative Recurrent Laryngeal Nerve Monitoring
A study testing Lidocaine in people with Thyroid Cancer and Neck Cancer, run by Bo Wang,MD at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer, Neck Cancer, Recurrent Laryngeal Nerve Injuries
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thyroid papillary carcinoma
- Lateral cervical lymph node metastasis
- The diameter of the metastatic lymph nodes is less than 3cm
- Without internal jugular vein invasion
Who cannot join
- Lidocaine allergy sufferers
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
bo wang, md, 13705947900, wangbo@fjmu.edu.cn
About this study
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
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.
- Conditions
- Thyroid Cancer, Neck Cancer, Recurrent Laryngeal Nerve Injuries, Accessory Nerve Injuries, EMG: Repetitive Nerve Stimulation Abnormality
- Being tested
- Lidocaine
- Medical subject headings
- Thyroid Neoplasms, Head and Neck Neoplasms, Recurrent Laryngeal Nerve Injuries, Accessory Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Local injection of lidocaine reduces muscle tremor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose of muscle relaxant drugs
dose of muscle relaxant drugs
Measured: At the end of surgery
dose of lidocaine
dose of lidocaine
Measured: At the end of surgery
Number of nerve signal loss cases
Number of nerve signal loss cases
Measured: At the end of surgery
Anatomical time of accessory nerve
Anatomical time of accessory nerve
Measured: 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.
Measured: At the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start1 May 2018
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Wang,MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Wang,MD, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530033
- Sponsor's protocol ID
- BND IONM Lidocaine
- Status last verified
- Sep 2018
- First submitted
- 8 May 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03530033
- Acronym / sponsor ID
- BND IONM Lidocaine
- Conditions
- Thyroid Cancer, Neck Cancer, Recurrent Laryngeal Nerve Injuries, Accessory Nerve Injuries, EMG: Repetitive Nerve Stimulation Abnormality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bo Wang,MDUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: LidocaineAnesthesia 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Thyroid papillary carcinoma
- Lateral cervical lymph node metastasis
- The diameter of the metastatic lymph nodes is less than 3cm
- Without internal jugular vein invasion
Key exclusion criteria (1 listed)
- Lidocaine allergy sufferers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineLocal injection of lidocaine reduces muscle tremor | Drug | Lidocaine group |
Primary outcome
dose of muscle relaxant drugs
Time frame: At the end of surgery
dose of muscle relaxant drugs
dose of lidocaine
Time frame: At the end of surgery
dose of lidocaine
Number of nerve signal loss cases
Time frame: At the end of surgery
Number of nerve signal loss cases
Anatomical time of accessory nerve
Time frame: At the end of surgery
Anatomical time of accessory nerve
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Thyroid Cancer and Neck Cancer, run by Bo Wang,MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bo wang, md (13705947900, wangbo@fjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose of muscle relaxant drugs (time frame: At the end of surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2018.