Skip to main content
OpenTrials
Completed

NCT Number: NCT04574947

Lidocaine And Neuromonitoring in Thyroid Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

St. Petersburg State University Hospital

Saint Petersburg, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Lidocaine

Drug

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

Drug

During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.

Intra-cuff lidocaine

Procedure

The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.

Intra-cuff placebo

Procedure

The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.

Primary outcomes

  1. Quality of recovery 40 questionnaire

    Time frame: First postoperative day

    Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes

Secondary outcomes

  1. Hypotension incidence

    Time frame: Intraoperative

    Incidence of arterial hypotension (SBP <60 mm Hg)

  2. Hypotension duration

    Time frame: Intraoperative

    Cumulative duration of arterial hypotension (SBP <60 mm Hg) expressed in minutes

  3. Cough rate

    Time frame: In the operating room and during awakening.

    Frequency of laryngeal reflexes

  4. Minimal bispectral index

    Time frame: During surgery

    Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.

  5. Bispectral index less then 40

    Time frame: During surgery

    Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.

  6. Amplitude

    Time frame: During surgery

    Amplitude of electromyographic potential during neuromonitoring of recurrent nerve

  7. Latency

    Time frame: During surgery

    Latency of electromyographic potential during neuromonitoring of recurrent nerve

Sponsors and collaborators

Lead sponsor

Saint Petersburg State University, Russia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 5, 2020
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.