Continuous Lidocaine Infusion in Thyroid Surgery Using Intraoperative Neurophysiological Monitoring

NCT06785987 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: KSVGH24-CT1-12 2024.2.7
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Disease; Thyroid Surgery; Lidocaine Infusion

Keywords

lidocaine; Thyroid surgery

Outcome Measures

Primary Outcomes (1)

• bucking and inadequate depth of anesthesia incidence

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

  Perioperative

Secondary Outcomes (7)

• Surgeon satisfaction

  Perioperative

• Perioperative fentanyl usage

  Perioperative

• Post operative analgesia requirement

  24 hours postoperative

• Perioperative hemodynamic stability

  perioperative

• Prolonged sedation

  Post operative to leaving PACU

Other Outcomes (1)

• dosage of fentanyl, remifentanil and lidocaine.

  Perioperative

Study Arms (3)

intermittent fentanyl infusion

ACTIVE COMPARATOR

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

Drug: intermittent fentanyl infusion

Continuous Lidocaine Infusion

EXPERIMENTAL

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

Drug: Continuous Lidocaine Infusion

Continuous remifentanil Infusion

ACTIVE COMPARATOR

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

Drug: Continuous remifentanil Infusion

Interventions

Continuous Lidocaine Infusion DRUG

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

Also known as: Lidocaine

Continuous Lidocaine Infusion

intermittent fentanyl infusion DRUG

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

intermittent fentanyl infusion

Continuous remifentanil Infusion DRUG

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

Continuous remifentanil Infusion

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Kaohsiung veterans general hospital

Kaohsiung, Taiwan, 813, Taiwan

Location

Related Publications (8)

• 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.

  PMID: 27379388 BACKGROUND

• 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.

  PMID: 22584558 BACKGROUND

• 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.

  PMID: 24036842 BACKGROUND

• 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.

  PMID: 30117019 BACKGROUND

• 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.

  PMID: 21205628 BACKGROUND

• 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.

  PMID: 24829420 BACKGROUND

• 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.

  PMID: 35454334 BACKGROUND

• 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.

  PMID: 34007359 BACKGROUND

MeSH Terms

Conditions

Thyroid Diseases

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Zhen Xiu Chen, M.D.

  Kaohsiung Veterans General Hospital.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The Participant will be under general anesthesia, masking the Participant from knowing the exact drugs using during the surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 22, 2025
• Study Start: February 7, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication and ending 3 years after the publication of results
• Access Criteria: describes planned analyses must be submitted

Locations

TW (1)