A Phase 4 interventional study of Intravenous lidocaine and Intravenous placebo in Thyroid Neoplasm, Parathyroid Neoplasms and Anesthesia, sponsored by Saint Petersburg State University, Russia. Completed at 1 site in Russian Federation. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Saint Petersburg State University, Russia · Phase 4, Interventional, and Treatment
The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo.
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.
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This study's enrollment of 110 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
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Exclusion Criteria:
Drug: Intravenous lidocaine · Procedure: Intra-cuff placebo
Drug: Intravenous placebo · Procedure: Intra-cuff lidocaine
Drug: Intravenous placebo · Procedure: Intra-cuff placebo
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.
During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.
The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.
The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.
Quality of recovery 40 questionnaire
Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes
Time frame: First postoperative day
Hypotension incidence
Incidence of arterial hypotension (SBP \<60 mm Hg)
Time frame: Intraoperative
Hypotension duration
Cumulative duration of arterial hypotension (SBP \<60 mm Hg) expressed in minutes
Time frame: Intraoperative
Cough rate
Frequency of laryngeal reflexes
Time frame: In the operating room and during awakening.
Minimal bispectral index
Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.
Time frame: During surgery
Bispectral index less then 40
Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.
Time frame: During surgery
Amplitude
Amplitude of electromyographic potential during neuromonitoring of recurrent nerve
Time frame: During surgery
Latency
Latency of electromyographic potential during neuromonitoring of recurrent nerve
Time frame: During surgery
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Saint Petersburg State University, Russia