Lidocaine And Neuromonitoring in Thyroid Surgery
Study Details
Study Description
Brief Summary
The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intravenous lidocaine
|
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.
Procedure: 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.
|
| Experimental: Topical lidocaine
|
Drug: 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.
|
| Placebo Comparator: Placebo
|
Drug: 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 placebo
The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.
|
Outcome Measures
Primary Outcome Measures
- Quality of recovery 40 questionnaire [First postoperative day]
Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes
Secondary Outcome Measures
- Hypotension incidence [Intraoperative]
Incidence of arterial hypotension (SBP <60 mm Hg)
- Hypotension duration [Intraoperative]
Cumulative duration of arterial hypotension (SBP <60 mm Hg) expressed in minutes
- Cough rate [In the operating room and during awakening.]
Frequency of laryngeal reflexes
- Minimal bispectral index [During surgery]
Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.
- Bispectral index less then 40 [During surgery]
Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.
- Amplitude [During surgery]
Amplitude of electromyographic potential during neuromonitoring of recurrent nerve
- Latency [During surgery]
Latency of electromyographic potential during neuromonitoring of recurrent nerve
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Petersburg State University Hospital | Saint Petersburg | Russian Federation |
Sponsors and Collaborators
- Saint Petersburg State University, Russia
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IOLANT