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Thyroid DiseasePhase 4NCT06785987

Continuous Lidocaine Infusion in Thyroid Surgery Using Intraoperative Neurophysiological Monitoring

A Phase 4 study testing Continuous Lidocaine Infusion, intermittent fentanyl infusion and Continuous remifentanil Infusion in people with Thyroid Disease and Thyroid Surgery, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Thyroid surgery is a common procedure for the treatment of thyroid tumors, nodules and other related lesions. During this procedure, intraoperative neurophysiological monitoring is used to protect the recurrent laryngeal nerves. For the nerve monitor to work properly, a reduced muscle relaxant dosage is indicated. Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Continuous Lidocaine Infusion, intermittent fentanyl infusion and Continuous remifentanil Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTaiwan
Study dates
7 Feb 2024to 31 Mar 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 20-75 years old
  • Receiving open thyroid surgery
  • Using intraoperative neurophysiological monitoring

Who cannot join

  • Allergic to opioids or lidocaine.
  • Unsuitable for prolonged lidocaine infusion due to impaired cardiac function or severe arrhythmias.
  • Impaired renal function (eGFR < 30).
  • Liver dysfunction (Child-Pugh score B/C).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • Kaohsiung veterans general hospital

    Kaohsiung, Taiwan, 813

Other trials in Taiwan

About this study

Thyroid surgery is a common procedure for the treatment of thyroid tumors, nodules and other related lesions. During this procedure, intraoperative neurophysiological monitoring is used to protect the recurrent laryngeal nerves. For the nerve monitor to work properly, a reduced muscle relaxant dosage is indicated. The main objectives of the anesthesiologist are maintaining deep sedation, analgesia and immobilization during surgery, as well as enhance post-operative recovery. Reduced muscle relaxant use during surgery poses the risk of inadequate immobilization during the operation, which may result in serious surgical complications. Intravenous bolus administration of fentanyl is currently the most popular method to maintain the depth of anesthesia during such operations. However, the side effects include intraoperative hypotension, bradycardia, and postoperative nausea and vomiting. The ultra-short acting remifentanil may be appropriate for inhibiting the bucking reflex during surgery, but the risk of opioid-induced hyperalgesia and opioid tolerance after surgery has been reported. In recent studies, intravenous lidocaine has been shown to increase the depth of anesthesia and provide analgesia, with no muscle relaxing effect.

The aim of this study is to examine the depth of anesthesia, surgical operating conditions, and the recovery profile with the use of a continuous lidocaine infusion.

Read the detailed description
  1. Purpose of the Study: This study is a single-center clinical trial in Taiwan, targeting the enrollment of 150 participants. The primary goal is to evaluate the effects of lidocaine infusion in thyroid surgery and to analyze whether it differs from or offers advantages over conventional anesthetic methods. As with any treatment, risks are involved, and clinical trials are no exception. Please carefully consider your participation in this trial.
  2. Current Status of the Investigational Products:
  • Lidocaine (Local Anesthetic): Lidocaine is a commonly used local anesthetic for injection, as well as a routine intravenous anesthetic induction drug in general anesthesia. It is also frequently used to treat arrhythmias. Large-scale data analyses confirm its high safety profile. Continuous infusion has been shown to enhance intraoperative sedation and postoperative pain relief. -Fentanyl and Remifentanil (Systemic Analgesics): Fentanyl and its ultra-short-acting variant, remifentanil, are the most commonly used opioid analgesics in surgical anesthesia.
  1. Inclusion and Exclusion Criteria: Physicians or research staff at our hospital will discuss the necessary conditions for participation with you. Please provide honest information about your medical history.
  • Inclusion Criteria: Age: 20-75 years Diagnosed with thyroid nodules or tumors Recommended for surgical excision by general surgeons or otolaryngologists Use of recurrent laryngeal nerve monitoring during surgery
  • Exclusion Criteria: High anesthesia risk Liver or kidney function impairment Known allergies to anesthetic drugs used in the surgery (Sevoflurane, Propofol, Lidocaine, Remifentanil, Fentanyl)
  1. Study Methods and Procedures: -Preoperative Assessment: If you decide to join and sign the consent form, a routine preoperative health examination will be conducted, including blood and urine tests, height and weight measurements, heart rate and blood pressure monitoring, ECG, and chest X-rays. -Study Design: Participants will be randomly divided into three groups of 50 individuals. All participants will receive general anesthesia and intraoperative recurrent laryngeal nerve monitoring. Each group will have a different anesthesia and pain management approach:
  • Group P (Intermittent Fentanyl Infusion): Maintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion.
  • Group L (Continuous Lidocaine Infusion): Maintained with sevoflurane and continuous lidocaine infusion.
  • Group R (Continuous Remifentanil Infusion): Maintained with sevoflurane and continuous remifentanil infusion. All other anesthesia procedures will follow routine clinical practice. During the surgery, the following will be monitored and recorded: -Intraoperative vital signs (heart rate, blood pressure, oxygen saturation) -Anesthesia parameters (e.g., inhaled anesthetic concentration, bispectral index(BIS) monitoring, neuromuscular response) -Surgery quality, occurrences of bucking, and duration Dosages of fentanyl, remifentanil, and lidocaine used Postoperative evaluations include: -Surgical environment quality assessed by the surgeon -Recovery scores using the Aldrete scoring system -Pain scores (VAS, 1-10) in the recovery room
  • Analgesic use within 24 hours post-surgery
  • On the first postoperative day, a nurse will assess recovery, side effects (e.g., sore throat, nausea), and pain levels. Appropriate treatments will be provided if necessary.
  1. Potential Side Effects and Management: Risks Associated with Investigational Products:
  • Common (<10%): Circulatory: Mild bradycardia, slight increase in blood pressure Central nervous system(CNS): Paresthesia, dizziness Gastrointestinal: Mild nausea or vomiting -Uncommon (<1%): Central nervous system(CNS): Central nervous toxicity (seizures, perioral numbness, tongue numbness, auditory hypersensitivity, confusion, mild headache, tinnitus, slurred speech) -Rare (<0.1%): Severe allergic reactions: Anaphylactic shock Central nervous system(CNS): Neuropathy, peripheral nerve damage, arachnoiditis, unconsciousness, tremors Cardiac: Cardiac arrest, arrhythmias Respiratory: Respiratory depression
  • Management of Serious Adverse Effects: Immediately stop the local anesthetic infusion and provide emergency treatment for systemic toxicity symptoms. For seizures, administer anticonvulsants (e.g., thiopental 100-500 mg IV, diazepam 5-10 mg IV). If needed, administer suxamethonium for muscle relaxation. For cardiovascular instability, administer ephedrine (5-10 mg IV), and repeat if necessary. If cardiac arrest occurs, initiate cardiopulmonary resuscitation.
  • Risks of Routine General Anesthesia: Propofol (IV anesthetic): May cause mild bradycardia; very rarely (<0.0014%) may result in severe bradycardia. Sevoflurane (inhaled anesthetic): May cause mild bradycardia, hypotension, or postoperative nausea/vomiting (30-40%). Fentanyl/Remifentanil: May cause mild bradycardia, hypotension, or postoperative nausea/vomiting (10-50%). -Management: For severe bradycardia or hypotension, appropriate medications will be administered. For nausea or vomiting, antiemetics will be provided as needed. -If any severe side effects occur, please: Contact the 24-hour emergency hotline. Seek medical attention at the nearest emergency room if necessary.
Being tested
Continuous Lidocaine Infusion, intermittent fentanyl infusion, Continuous remifentanil Infusion
Keywords
lidocaine, Thyroid surgery
Medical subject headings
Thyroid Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Lidocaine InfusionDrug

    Also called Lidocaine

    Maintained with sevoflurane and continuous lidocaine infusion under dosage: 1.5 mg/kg/hr

  • intermittent fentanyl infusionDrug

    Maintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion.

  • Continuous remifentanil InfusionDrug

    Maintained with sevoflurane and continuous remifentanil infusion under dosage: 3-5μg /kg/hr

Study groups in NCT06785987
Study groupRoleWhat they receive
intermittent fentanyl infusionActive comparatorMaintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion.
Receives: Drug: intermittent fentanyl infusion
Continuous Lidocaine InfusionExperimentalMaintained with sevoflurane and continuous lidocaine infusion under dosage: 1.5 mg/kg/hr
Receives: Drug: Continuous Lidocaine Infusion
Continuous remifentanil InfusionActive comparatorMaintained with sevoflurane and continuous remifentanil infusion under dosage: 3-5μg /kg/hr
Receives: Drug: Continuous remifentanil Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. bucking and inadequate depth of anesthesia incidence

    participants bucking and inadequate depth of anesthesia incidence counts during the surgery

    Measured: Perioperative

Secondary outcomes (7)
  1. Surgeon satisfaction

    Surgeon satisfaction during surgery in scale of 1-3, 1 as most-satisfied, 3 as unsatisfied.

    Measured: Perioperative

  2. Perioperative fentanyl usage

    Perioperative fentanyl usage

    Measured: Perioperative

  3. Post operative analgesia requirement

    Analgesia requirement during firs 24 hours after surgery

    Measured: 24 hours postoperative

  4. Perioperative hemodynamic stability

    Perioperative hemodynamic stability(SBP with 20% compared to preoperative)

    Measured: perioperative

  5. Prolonged sedation

    Record patient's consciousness level using Aldrete score: right after extubation, upon arrival at post anesthesia care unit(PACU)(10 minutes after surgery), and on leaving PACU(60 minutes after surgery).

    Measured: Post operative to leaving PACU

  6. VAS score while in post anesthesia care unit(PACU)

    VAS score while in PACU in 15 minutes, 30 minutes and 60 minues.

    Measured: Post operative to leaving PACU

  7. postoperative side effects (sore throat, postoperative nausea and vomiting etc.)

    postoperative side effects (sore throat, postoperative nausea and vomiting, etc.)

    Measured: 24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start7 Feb 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06785987
Sponsor's protocol ID
KSVGH24-CT1-12 2024.2.7
Status last verified
Mar 2026
First submitted
10 Jan 2025
Last updated
1 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: all individual participant data (IPD) that underlie results in a publication

Publications

  • Choi GJ, Kang H, Ahn EJ, Oh JI, Baek CW, Jung YH, Kim JY. Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. World J Surg. 2016 Dec;40(12):2941-2947. doi: 10.1007/s00268-016-3619-6.

    PubMed 27379388
  • De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14.

    PubMed 22584558
  • De Oliveira GS Jr, Duncan K, Fitzgerald P, Nader A, Gould RW, McCarthy RJ. Systemic lidocaine to improve quality of recovery after laparoscopic bariatric surgery: a randomized double-blinded placebo-controlled trial. Obes Surg. 2014 Feb;24(2):212-8. doi: 10.1007/s11695-013-1077-x.

    PubMed 24036842
  • Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.

    PubMed 30117019
  • Lee JH, Koo BN, Jeong JJ, Kim HS, Lee JR. Differential effects of lidocaine and remifentanil on response to the tracheal tube during emergence from general anaesthesia. Br J Anaesth. 2011 Mar;106(3):410-5. doi: 10.1093/bja/aeq396. Epub 2011 Jan 2.

    PubMed 21205628
  • Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.

    PubMed 24829420
  • Hsieh CY, Tan H, Huang HF, Huang TY, Wu CW, Chang PY, Lu DV, Lu IC. Optimization of Intraoperative Neural Monitoring of the Recurrent Laryngeal Nerve in Thyroid Surgery. Medicina (Kaunas). 2022 Mar 30;58(4):495. doi: 10.3390/medicina58040495.

    PubMed 35454334
  • Govindarajan R, Shah A, Ravikumar S, Reddy SK, Kannan U, Mukerji AN, Cherian JG, Foster C, Livingstone D. Lidocaine Infusion Improves the Functionality of Intraoperative Nerve Monitoring During Thyroid Surgery: A Prospective, Randomized, Double-Blinded Study. J Clin Med Res. 2021 Apr;13(4):214-221. doi: 10.14740/jocmr4458. Epub 2021 Apr 27.

    PubMed 34007359

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Continuous Lidocaine Infusion, intermittent fentanyl infusion and Continuous remifentanil Infusion in people with Thyroid Disease and Thyroid Surgery, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. 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 Taiwan. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

bucking and inadequate depth of anesthesia incidence (time frame: Perioperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06785987, which also lists 8 linked publications.

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 1 Apr 2026.

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