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.
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
- Conditions the study is for
- Thyroid Disease, Thyroid Surgery, Lidocaine Infusion
- 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.
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
- 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.
- 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.
- 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)
- 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.
- 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.
- Conditions
- Thyroid Disease, Thyroid Surgery, Lidocaine Infusion
- 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 group | Role | What they receive |
|---|---|---|
| intermittent fentanyl infusion | Active comparator | Maintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion. Receives: Drug: intermittent fentanyl infusion |
| Continuous Lidocaine Infusion | Experimental | Maintained with sevoflurane and continuous lidocaine infusion under dosage: 1.5 mg/kg/hr Receives: Drug: Continuous Lidocaine Infusion |
| Continuous remifentanil Infusion | Active comparator | Maintained 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.
bucking and inadequate depth of anesthesia incidence
participants bucking and inadequate depth of anesthesia incidence counts during the surgery
Measured: Perioperative
Secondary outcomes (7)
Surgeon satisfaction
Surgeon satisfaction during surgery in scale of 1-3, 1 as most-satisfied, 3 as unsatisfied.
Measured: Perioperative
Perioperative fentanyl usage
Perioperative fentanyl usage
Measured: Perioperative
Post operative analgesia requirement
Analgesia requirement during firs 24 hours after surgery
Measured: 24 hours postoperative
Perioperative hemodynamic stability
Perioperative hemodynamic stability(SBP with 20% compared to preoperative)
Measured: perioperative
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
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
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.
- First posted22 Jan 2025
- Study start7 Feb 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Huai-Jhih, Kaohsiung Veterans General Hospital.
- Investigators
- Zhen Xiu Chen, M.D., Study chair, Kaohsiung Veterans General Hospital.
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 27379388De 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 22584558De 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 24036842Beaussier 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 30117019Lee 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 21205628Fletcher 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 24829420Hsieh 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 35454334Govindarajan 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Lidocaine Infusion in Thyroid Surgery Using Intraoperative Neurophysiological Monitoring
- ClinicalTrials.gov ID
- NCT06785987
- Acronym / sponsor ID
- KSVGH24-CT1-12 2024.2.7
- Conditions
- Thyroid Disease, Thyroid Surgery, Lidocaine Infusion
- Keywords
- lidocaine, Thyroid surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jan 2025 (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.
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.
Detailed description
- 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.
- 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.
- 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)
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intermittent fentanyl infusion | Active comparator | Drug: intermittent fentanyl infusionMaintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion. |
| Continuous Lidocaine Infusion | Experimental | Drug: Continuous Lidocaine InfusionMaintained with sevoflurane and continuous lidocaine infusion under dosage: 1.5 mg/kg/hr |
| Continuous remifentanil Infusion | Active comparator | Drug: Continuous remifentanil InfusionMaintained with sevoflurane and continuous remifentanil infusion under dosage: 3-5μg /kg/hr |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 20-75 years old
- Receiving open thyroid surgery
- Using intraoperative neurophysiological monitoring
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Continuous Lidocaine InfusionAlso: LidocaineMaintained with sevoflurane and continuous lidocaine infusion under dosage: 1.5 mg/kg/hr | Drug | Continuous Lidocaine Infusion |
| intermittent fentanyl infusionMaintained with volatile anesthetic gas (sevoflurane) and intermittent fentanyl infusion. | Drug | intermittent fentanyl infusion |
| Continuous remifentanil InfusionMaintained with sevoflurane and continuous remifentanil infusion under dosage: 3-5μg /kg/hr | Drug | Continuous remifentanil Infusion |
Primary outcome
bucking and inadequate depth of anesthesia incidence
Time frame: Perioperative
participants bucking and inadequate depth of anesthesia incidence counts during the surgery
7 secondary outcomes
Surgeon satisfaction
Time frame: Perioperative
Perioperative fentanyl usage
Time frame: Perioperative
Post operative analgesia requirement
Time frame: 24 hours postoperative
Perioperative hemodynamic stability
Time frame: perioperative
Prolonged sedation
Time frame: Post operative to leaving PACU
VAS score while in post anesthesia care unit(PACU)
Time frame: Post operative to leaving PACU
postoperative side effects (sore throat, postoperative nausea and vomiting etc.)
Time frame: 24 hours postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Background: PubMed 27379388Choi 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.
- Background: PubMed 22584558De 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.
- Background: PubMed 24036842De 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.
- Background: PubMed 30117019Beaussier 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.
- Background: PubMed 21205628Lee 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.
- Background: PubMed 24829420Fletcher 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.
- Background: PubMed 35454334Hsieh 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.
- Background: PubMed 34007359Govindarajan 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.
- Individual participant dataSharing planned: Yes. all individual participant data (IPD) that underlie results in a publication
Related trials for Thyroid Disease
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Recruiting
Ultrasound-guided Microwave Ablation of Benign Thyroid Nodules
Thyroid Nodule (Diagnosis)
Not yet recruiting
Endotracheal Tube Versus Transcartilage Needle Electrodes for Nerve Monitoring in Thyroid Surgery
Thyroid Diseases, Recurrent Laryngeal Nerve Injury
RecruitingPhase 2
Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease
Graves' Disease
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.
Zhen Xiu Chen, M.D. study chair
Kaohsiung Veterans General Hospital.
1 site in 1 country: see every site and its status.
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.