Continuous Lidocaine Infusion in Thyroid Surgery Using Intraoperative Neurophysiological Monitoring

March 31, 2026 updated by: Sun Huai-Jhih, Kaohsiung Veterans General Hospital.

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

  3. 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)

  4. 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.

  5. 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Kaohsiung, Taiwan, Taiwan, 813
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intermittent fentanyl infusion
Maintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion.
Drug: intermittent fentanyl infusion
Maintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion.
Experimental: Continuous Lidocaine Infusion
Maintained with sevoflurane and continuous lidocaine infusion under dosage: 1.5 mg/kg/hr
Drug: Continuous Lidocaine Infusion
Maintained with sevoflurane and continuous lidocaine infusion under dosage: 1.5 mg/kg/hr
Other Names:
  • Lidocaine
Active Comparator: Continuous remifentanil Infusion
Maintained with sevoflurane and continuous remifentanil infusion under dosage: 3-5μg /kg/hr
Drug: Continuous remifentanil Infusion
Maintained with sevoflurane and continuous remifentanil infusion under dosage: 3-5μg /kg/hr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bucking and inadequate depth of anesthesia incidence
Time Frame: Perioperative
participants bucking and inadequate depth of anesthesia incidence counts during the surgery
Perioperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon satisfaction
Time Frame: Perioperative
Surgeon satisfaction during surgery in scale of 1-3, 1 as most-satisfied, 3 as unsatisfied.
Perioperative
Perioperative fentanyl usage
Time Frame: Perioperative
Perioperative fentanyl usage
Perioperative
Post operative analgesia requirement
Time Frame: 24 hours postoperative
Analgesia requirement during firs 24 hours after surgery
24 hours postoperative
Perioperative hemodynamic stability
Time Frame: perioperative
Perioperative hemodynamic stability(SBP with 20% compared to preoperative)
perioperative
Prolonged sedation
Time Frame: Post operative to leaving PACU
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).
Post operative to leaving PACU
VAS score while in post anesthesia care unit(PACU)
Time Frame: Post operative to leaving PACU
VAS score while in PACU in 15 minutes, 30 minutes and 60 minues.
Post operative to leaving PACU
postoperative side effects (sore throat, postoperative nausea and vomiting etc.)
Time Frame: 24 hours postoperative
postoperative side effects (sore throat, postoperative nausea and vomiting, etc.)
24 hours postoperative

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
dosage of fentanyl, remifentanil and lidocaine.
Time Frame: Perioperative
dosage of fentanyl, remifentanil and lidocaine.
Perioperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Study Chair: Zhen Xiu Chen, M.D., Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSVGH24-CT1-12 2024.2.7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all individual participant data (IPD) that underlie results in a publication

IPD Sharing Time Frame

Beginning 1 year after publication and ending 3 years after the publication of results

IPD Sharing Access Criteria

describes planned analyses must be submitted

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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