Lidocaine And Neuromonitoring in Thyroid Surgery

Intravenous Or Topical Lidocaine And Neuromonitoring in Thyroid Surgery (IOLANT Study)

The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Parathyroid Neoplasms; Thyroid Neoplasm
• Intervention / Treatment: Drug: Intravenous lidocaine; Procedure: Intra-cuff placebo; Drug: Intravenous placebo; Procedure: Intra-cuff lidocaine

Detailed Description

The use of neuromonitoring in thyroid surgery imposes a number of special demands for anaesthetic management. Such demands include avoiding muscle relaxation and local anaesthesia. Maintaining a balance between the risk of awakening during surgery and excessively deep anaesthesia in fast track surgery is an important task for the anaesthesiologist.

Mild anaesthesia in the absence of muscle relaxation increases the risk of developing laryngeal reflexes, coughing during surgery, while excessively deep anaesthesia slows down recovery after surgery and increases the risk of arterial hypotension. The frequency and duration of arterial hypotension, as well as the depth of anesthesia assessed by the Bispectral index, are independent risk factors for postoperative cardiovascular complications and long-term mortality. On the other hand, coughing in response to irritation of the endotracheal tube during recovery from anesthesia is recognized as a risk factor for respiratory and cardiovascular complications, as well as postoperative wound insufficiency.

Optimization the anesthesia by intravenous infusion of lidocaine can improve anesthesia controllability, hemodynamic stability and overall anesthesia recovery rates. Local use of lidocaine, including filling the endotracheal tube cuff with its alkalinized solution, has also been shown to be effective in reducing the frequency of laryngeal reflexes upon awakening after surgery of varying duration. However, the efficacy and safety of local use of lidocaine under neuromonitoring conditions has not been studied. Despite recommendations to avoid the local use of lidocaine for tracheal intubation, there is evidence of the safety of this technique in the absence of a negative impact on the quality of neuromonitoring.

The purpose of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo. At the same time, the investigators assume that recovery after surgery will be comparable with both local and intravenous use. Intergroup differences in arterial hypotension, depth of anesthesia and intraoperative neuromonitoring parameters will also be investigated.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sergey Efremov; Phone Number: 79137946090; Email: sergefremov@mail.ru
• Study Contact Backup: Name: Alexey Kulikov; Phone Number: 79217896909; Email: alexeykulikov1987@yandex.ru

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation
    • St. Petersburg State University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Planned thyroid surgery
• Age> 45 years
• Signed informed consent to participate in the study

Exclusion Criteria:

• Emergency surgery
• Redo surgery
• Contraindications for lidocaine use
• Pregnancy
• Enrolment to another randomised clinical trial within the last 30 days

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Procedure: Intra-cuff placebo; The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.; Drug: Intravenous placebo; During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.
Active Comparator: Intravenous lidocaine	Drug: Intravenous lidocaine; Lidocaine IV 1.5 mg / kg BMI will be administered during induction into anaesthesia followed by infusion at a dose of 1.5 mg / kg / h until the end of the surgery.; Procedure: Intra-cuff placebo; The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.
Experimental: Topical lidocaine	Drug: Intravenous placebo; During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.; Procedure: Intra-cuff lidocaine; The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of recovery 40 questionnaire	Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes	First postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypotension incidence	Incidence of arterial hypotension (SBP <60 mm Hg)	Intraoperative
Hypotension duration	Cumulative duration of arterial hypotension (SBP <60 mm Hg) expressed in minutes	Intraoperative
Cough rate	Frequency of laryngeal reflexes	In the operating room and during awakening.
Minimal bispectral index	Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.	During surgery
Bispectral index less then 40	Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.	During surgery
Amplitude	Amplitude of electromyographic potential during neuromonitoring of recurrent nerve	During surgery
Latency	Latency of electromyographic potential during neuromonitoring of recurrent nerve	During surgery

Collaborators and Investigators

• Sponsor: Saint Petersburg State University, Russia

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Parathyroid Diseases; Head and Neck Neoplasms; Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Parathyroid Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IOLANT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• 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