Lidocaine And Neuromonitoring in Thyroid Surgery

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

Detailed Description
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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.

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

Conditions
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Thyroid Neoplasm, Parathyroid Neoplasms, Anesthesia

Intervention / Treatment
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* Drug: Intravenous lidocaine
* Drug: Intravenous placebo
* Procedure: Intra-cuff lidocaine
* Procedure: Intra-cuff placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous lidocaine<br> | Drug: Intravenous lidocaine<br>* 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.<br>Procedure: Intra-cuff placebo<br>* The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.<br>|
| Experimental: Topical lidocaine<br> | Drug: Intravenous placebo<br>* During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.<br>Procedure: Intra-cuff lidocaine<br>* The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.<br>|
| Placebo Comparator: Placebo<br> | Drug: Intravenous placebo<br>* During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.<br>Procedure: Intra-cuff placebo<br>* The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.<br>|

What is the study measuring?
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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 |