Lidocaine And Neuromonitoring in Thyroid Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04574947
• Other study ID #: IOLANT
• Status: Completed
• Phase: Phase 4
• Start date: January 25, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: Saint Petersburg State University, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Neoplasms
• Parathyroid Neoplasms
• Thyroid Diseases
• Thyroid Neoplasm
• Thyroid Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Russian Federation	St. Petersburg State University Hospital	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery 40 questionnaire	Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes	First postoperative day
Secondary	Hypotension incidence	Incidence of arterial hypotension (SBP <60 mm Hg)	Intraoperative
Secondary	Hypotension duration	Cumulative duration of arterial hypotension (SBP <60 mm Hg) expressed in minutes	Intraoperative
Secondary	Cough rate	Frequency of laryngeal reflexes	In the operating room and during awakening.
Secondary	Minimal bispectral index	Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.	During surgery
Secondary	Bispectral index less then 40	Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.	During surgery
Secondary	Amplitude	Amplitude of electromyographic potential during neuromonitoring of recurrent nerve	During surgery
Secondary	Latency	Latency of electromyographic potential during neuromonitoring of recurrent nerve	During surgery