Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
110 participants
INTERVENTIONAL
2021-01-25
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intravenous lidocaine
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.
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.
Topical lidocaine
Intravenous placebo
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
The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.
Placebo
Intravenous placebo
During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to 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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Age\> 45 years
* Signed informed consent to participate in the study
Exclusion Criteria
* Redo surgery
* Contraindications for lidocaine use
* Pregnancy
* Enrolment to another randomised clinical trial within the last 30 days
45 Years
ALL
No
Sponsors
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Saint Petersburg State University, Russia
OTHER
Responsible Party
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Efremov Sergey
Principal investigator
Locations
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St. Petersburg State University Hospital
Saint Petersburg, , Russia
Countries
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Other Identifiers
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IOLANT
Identifier Type: -
Identifier Source: org_study_id
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