Clinical trial NCT04574947: Lidocaine And Neuromonitoring in Thyroid Surgery
Official title: Intravenous Or Topical Lidocaine And Neuromonitoring in Thyroid Surgery (IOLANT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroid Neoplasm
Parathyroid Neoplasms
Anesthesia
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 110
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of recovery 40 questionnaire
timeFrame: First postoperative day
Secondary outcomes:
measure: Hypotension incidence
timeFrame: Intraoperative
measure: Hypotension duration
timeFrame: Intraoperative
measure: Cough rate
timeFrame: In the operating room and during awakening.
measure: Minimal bispectral index
timeFrame: During surgery
measure: Bispectral index less then 40
timeFrame: During surgery
measure: Amplitude
timeFrame: During surgery
measure: Latency
timeFrame: During surgery
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State University Hospital
Study officials:
References: