Lidocaine And Neuromonitoring in Thyroid Surgery
Primary Purpose
Thyroid Neoplasm, Parathyroid Neoplasms, Anesthesia
Status
Recruiting
Phase
Phase 4
Locations
Russian Federation
Study Type
Interventional
Intervention
Intravenous lidocaine
Intravenous placebo
Intra-cuff lidocaine
Intra-cuff placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thyroid Neoplasm
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
Sites / Locations
- St. Petersburg State University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
Intravenous lidocaine
Topical lidocaine
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Quality of recovery 40 questionnaire
Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes
Secondary Outcome Measures
Hypotension incidence
Incidence of arterial hypotension (SBP <60 mm Hg)
Hypotension duration
Cumulative duration of arterial hypotension (SBP <60 mm Hg) expressed in minutes
Cough rate
Frequency of laryngeal reflexes
Minimal bispectral index
Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.
Bispectral index less then 40
Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.
Amplitude
Amplitude of electromyographic potential during neuromonitoring of recurrent nerve
Latency
Latency of electromyographic potential during neuromonitoring of recurrent nerve
Full Information
NCT ID
NCT04574947
First Posted
September 24, 2020
Last Updated
August 30, 2022
Sponsor
Saint Petersburg State University, Russia
1. Study Identification
Unique Protocol Identification Number
NCT04574947
Brief Title
Lidocaine And Neuromonitoring in Thyroid Surgery
Official Title
Intravenous Or Topical Lidocaine And Neuromonitoring in Thyroid Surgery (IOLANT Study)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
November 15, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saint Petersburg State University, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasm, Parathyroid Neoplasms, Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravenous lidocaine
Arm Type
Active Comparator
Arm Title
Topical lidocaine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Intravenous lidocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous placebo
Intervention Description
During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.
Intervention Type
Procedure
Intervention Name(s)
Intra-cuff lidocaine
Intervention Description
The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.
Intervention Type
Procedure
Intervention Name(s)
Intra-cuff placebo
Intervention Description
The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.
Primary Outcome Measure Information:
Title
Quality of recovery 40 questionnaire
Description
Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes
Time Frame
First postoperative day
Secondary Outcome Measure Information:
Title
Hypotension incidence
Description
Incidence of arterial hypotension (SBP <60 mm Hg)
Time Frame
Intraoperative
Title
Hypotension duration
Description
Cumulative duration of arterial hypotension (SBP <60 mm Hg) expressed in minutes
Time Frame
Intraoperative
Title
Cough rate
Description
Frequency of laryngeal reflexes
Time Frame
In the operating room and during awakening.
Title
Minimal bispectral index
Description
Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.
Time Frame
During surgery
Title
Bispectral index less then 40
Description
Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.
Time Frame
During surgery
Title
Amplitude
Description
Amplitude of electromyographic potential during neuromonitoring of recurrent nerve
Time Frame
During surgery
Title
Latency
Description
Latency of electromyographic potential during neuromonitoring of recurrent nerve
Time Frame
During surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Efremov
Phone
79137946090
Email
sergefremov@mail.ru
First Name & Middle Initial & Last Name or Official Title & Degree
Alexey Kulikov
Phone
79217896909
Email
alexeykulikov1987@yandex.ru
Facility Information:
Facility Name
St. Petersburg State University Hospital
City
Saint Petersburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efremov Sergey, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexey Kulikov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anna Zolotuho
First Name & Middle Initial & Last Name & Degree
Viktor Makarin, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ilya Sleptsov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Oleg Kuleshov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Roman Chernikov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Alexandr Khomenko, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Lidocaine And Neuromonitoring in Thyroid Surgery
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