Clinical trial NCT06785987: Continuous Lidocaine Infusion in Thyroid Surgery Using Intraoperative Neurophysiological Monitoring
Official title: Continuous Lidocaine Infusion in Thyroid Surgery Using Intraoperative Neurophysiological Monitoring
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Thyroid Disease
Thyroid Surgery
Lidocaine Infusion
Keywords: lidocaine
Thyroid surgery
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: bucking and inadequate depth of anesthesia incidence
timeFrame: Perioperative
Secondary outcomes:
measure: Surgeon satisfaction
timeFrame: Perioperative
measure: Perioperative fentanyl usage
timeFrame: Perioperative
measure: Post operative analgesia requirement
timeFrame: 24 hours postoperative
measure: Perioperative hemodynamic stability
timeFrame: perioperative
measure: Prolonged sedation
timeFrame: Post operative to leaving PACU
measure: VAS score while in post anesthesia care unit(PACU)
timeFrame: Post operative to leaving PACU
measure: postoperative side effects (sore throat, postoperative nausea and vomiting etc.)
timeFrame: 24 hours postoperative
Other outcomes:
measure: dosage of fentanyl, remifentanil and lidocaine.
timeFrame: Perioperative
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung veterans general hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Zhen Xiu Chen, M.D.
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.