Thyroid NeoplasmPhase 4NCT04574947
Lidocaine And Neuromonitoring in Thyroid Surgery
A Phase 4 study testing Intravenous lidocaine and Intra-cuff lidocaine in people with Thyroid Neoplasm and Parathyroid Neoplasms, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Thyroid Neoplasm, Parathyroid Neoplasms, Anesthesia
- What is being tested?
- Intravenous lidocaine and Intra-cuff lidocaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 25 Jan 2021to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned thyroid surgery
- Age> 45 years
- Signed informed consent to participate in the study
Who cannot join
- Emergency surgery
- Redo surgery
- Contraindications for lidocaine use
- Pregnancy
- Enrolment to another randomised clinical trial within the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Or Topical Lidocaine And Neuromonitoring in Thyroid Surgery (IOLANT Study)
The aim of this study is to test the hypothesis that the quality of recovery with topical lidocaine is better than placebo.
Read the 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.
- Conditions
- Thyroid Neoplasm, Parathyroid Neoplasms, Anesthesia
- Being tested
- Intravenous lidocaine, Intravenous placebo, Intra-cuff lidocaine, Intra-cuff placebo
- Medical subject headings
- Thyroid Neoplasms, Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lidocaineDrug
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 placeboDrug
During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.
Intra-cuff lidocaineProcedure or surgery
The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.
Intra-cuff placeboProcedure or surgery
The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine | Active comparator | Not described Receives: Drug: Intravenous lidocaine; Procedure: Intra-cuff placebo |
| Topical lidocaine | Experimental | Not described Receives: Drug: Intravenous placebo; Procedure: Intra-cuff lidocaine |
| Placebo | Placebo comparator | Not described Receives: Drug: Intravenous placebo; Procedure: Intra-cuff placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery 40 questionnaire
Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes
Measured: First postoperative day
Secondary outcomes (7)
Hypotension incidence
Incidence of arterial hypotension (SBP <60 mm Hg)
Measured: Intraoperative
Hypotension duration
Cumulative duration of arterial hypotension (SBP <60 mm Hg) expressed in minutes
Measured: Intraoperative
Cough rate
Frequency of laryngeal reflexes
Measured: In the operating room and during awakening.
Minimal bispectral index
Minimal observed intraoperative bispectral index value. Values less than 40 mean a worse outcomes.
Measured: During surgery
Bispectral index less then 40
Cumulative duration of bispectral index less than 40. Values less than 40 mean a worse outcomes.
Measured: During surgery
Amplitude
Amplitude of electromyographic potential during neuromonitoring of recurrent nerve
Measured: During surgery
Latency
Latency of electromyographic potential during neuromonitoring of recurrent nerve
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start25 Jan 2021
- Primary completion15 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Efremov Sergey, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04574947
- Sponsor's protocol ID
- IOLANT
- Status last verified
- Mar 2024
- First submitted
- 24 Sep 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Or Topical Lidocaine And Neuromonitoring in Thyroid Surgery (IOLANT Study)
- ClinicalTrials.gov ID
- NCT04574947
- Acronym / sponsor ID
- IOLANT
- Conditions
- Thyroid Neoplasm, Parathyroid Neoplasms, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine | Active comparator | Drug: Intravenous lidocaine, Procedure: Intra-cuff placebo |
| Topical lidocaine | Experimental | Drug: Intravenous placebo, Procedure: Intra-cuff lidocaine |
| Placebo | Placebo comparator | Drug: Intravenous placebo, Procedure: Intra-cuff placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned thyroid surgery
- Age> 45 years
- Signed informed consent to participate in the study
Key exclusion criteria (5 listed)
- Emergency surgery
- Redo surgery
- Contraindications for lidocaine use
- Pregnancy
- Enrolment to another randomised clinical trial within the last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous lidocaineLidocaine 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. | Drug | Intravenous lidocaine |
| Intravenous placeboDuring induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution. | Drug | Placebo, Topical lidocaine |
| Intra-cuff lidocaineThe lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution. | Procedure or surgery | Topical lidocaine |
| Intra-cuff placeboThe intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution. | Procedure or surgery | Intravenous lidocaine, Placebo |
Primary outcome
Quality of recovery 40 questionnaire
Time frame: First postoperative day
Minimum and maximum values: 40 and 200, where higher scores mean a better outcomes
7 secondary outcomes
Hypotension incidence
Time frame: Intraoperative
Hypotension duration
Time frame: Intraoperative
Cough rate
Time frame: In the operating room and during awakening.
Minimal bispectral index
Time frame: During surgery
Bispectral index less then 40
Time frame: During surgery
Amplitude
Time frame: During surgery
Latency
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Yes
Related trials for Thyroid Neoplasm
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous lidocaine and Intra-cuff lidocaine in people with Thyroid Neoplasm and Parathyroid Neoplasms, run by Saint Petersburg State University, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of recovery 40 questionnaire (time frame: First postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.