LidocaineNCT06107543
Lidocaine in the Prevention of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation
An observational study of Lidocaine, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Direct laryngoscopy and endotracheal intubation procedure stimulate the sympathetic nervous system, causing catecholamine release into the circulation and consequently hemodynamic changes.There are many studies showing that lidocaine is used intravenously to suppress the sympathetic response to laryngoscopy and… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lidocaine
- What is being tested?
- Nebulized Lidocaine and Iv Lidocaine
- Type of treatment
- Injection or infusion
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 22 Jun 2024
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 80 patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia in the operating room will be included in the study.
Who may be able to join
- Patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia
Who cannot join
- Patients under the age of 18 and over the age of 80
- Patients who are not operated under general anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Training and Research Hospital
Kocaeli, 41900
About this study
Official title: Retrospective Investigation of the Effects of Different Uses of Lidocaine in the Prevention of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation
Direct laryngoscopy and endotracheal intubation procedure stimulate the sympathetic nervous system, causing catecholamine release into the circulation and consequently hemodynamic changes.There are many studies showing that lidocaine is used intravenously to suppress the sympathetic response to laryngoscopy and endotracheal intubation. Nebulized lidocaine is often used to provide upper airway local anesthesia in fiberoptic guided awake intubation.
In this study, the researchers aimed to compare the results of using intravenous lidocaine and nebulized lidocaine to suppress the hemodynamic response caused by laryngoscopy and endotracheal intubation retrospectively.
Researchers' hypothesis; Nebulized lidocaine administration is more effective than intravenous lidocaine administration in suppressing the hemodynamic response due to laryngoscopy and endotracheal intubation in patients under general anesthesia.
Read the detailed description
2% lidocaine drug to suppress the hemodynamic response due to laryngoscopy and endotracheal intubation; patients administered intravenously will be evaluated in one group, and patients administered inhaled through a nebulizer will be evaluated in another group.
Nebulized lidocaine in the researchers' clinic; it is administered by adding 2% lidocaine + physiological saline to a nebulizer and inhaling for 3-5 minutes in the presence of 4-6 liters/minute of oxygen.
Preoperative examination forms and intraoperative follow-up forms of the patients included in the study will be examined by the researchers. The dose of lidocaine applied and the method of administration will be recorded. In addition, the agents used in anesthesia induction (fentanyl, propofol, rocuronium bromide, etc.) and the hemodynamic changes of the patients (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure,oxygen saturation) will be recorded.
- Conditions
- Lidocaine
- Being tested
- Nebulized Lidocaine, Iv Lidocaine
- Keywords
- Lidocaine, Intubation, General anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulized LidocaineDrug
Before induction of anesthesia, 2% lidocaine + physiological saline was added to a nebulizer and inhaled for 3-5 minutes in the presence of 4-6 liters/minute of oxygen.
Iv LidocaineDrug
Intravenous %2 lidocaine was administered before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine | Patients who received lidocaine intravenously before induction of anesthesia will be considered in this group. Receives: Drug: Iv Lidocaine | |
| Nebulized lidocaine | Patients who received lidocaine by inhalation with a nebulizer before induction of anesthesia will be considered in this group. Receives: Drug: Nebulized Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)
Measured: Just before induction of anesthesia
Heart Rate
Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)
Measured: Immediately after induction of anesthesia
Heart Rate
Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)
Measured: 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
Blood Pressure
The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.
Measured: Just before induction of anesthesia
Blood Pressure
The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.
Measured: Immediately after induction of anesthesia
Blood Pressure
The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.
Measured: 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
Oxygen Saturation
The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.
Measured: Just before induction of anesthesia
Oxygen Saturation
The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.
Measured: Immediately after induction of anesthesia
Oxygen Saturation
The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.
Measured: 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Dec 2023
- Primary completion1 Jun 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LidocaineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atlı, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107543
- Sponsor's protocol ID
- DerinceTRH-EAtli-001
- Status last verified
- Jun 2024
- First submitted
- 4 Sep 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
Baronia AK, Singh PK, Maheshwari A, Jain VK, Mittal P, Pant KC. Inhaled lidocaine for prevention of hemodynamic changes in laryngoscopy and intubation. J Neurosurg Anesthesiol. 1992 Jul;4(3):154-9. doi: 10.1097/00008506-199207000-00002.
PubMed 15815458Sklar BZ, Lurie S, Ezri T, Krichelli D, Savir I, Soroker D. Lidocaine inhalation attenuates the circulatory response to laryngoscopy and endotracheal intubation. J Clin Anesth. 1992 Sep-Oct;4(5):382-5. doi: 10.1016/0952-8180(92)90160-3.
PubMed 1389192
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Investigation of the Effects of Different Uses of Lidocaine in the Prevention of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation
- ClinicalTrials.gov ID
- NCT06107543
- Acronym / sponsor ID
- DerinceTRH-EAtli-001
- Conditions
- Lidocaine
- Keywords
- Lidocaine, Intubation, General anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 30 Oct 2023 (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.
Direct laryngoscopy and endotracheal intubation procedure stimulate the sympathetic nervous system, causing catecholamine release into the circulation and consequently hemodynamic changes.There are many studies showing that lidocaine is used intravenously to suppress the sympathetic response to laryngoscopy and endotracheal intubation. Nebulized lidocaine is often used to provide upper airway local anesthesia in fiberoptic guided awake intubation.
In this study, the researchers aimed to compare the results of using intravenous lidocaine and nebulized lidocaine to suppress the hemodynamic response caused by laryngoscopy and endotracheal intubation retrospectively.
Researchers' hypothesis; Nebulized lidocaine administration is more effective than intravenous lidocaine administration in suppressing the hemodynamic response due to laryngoscopy and endotracheal intubation in patients under general anesthesia.
Detailed description
2% lidocaine drug to suppress the hemodynamic response due to laryngoscopy and endotracheal intubation; patients administered intravenously will be evaluated in one group, and patients administered inhaled through a nebulizer will be evaluated in another group.
Nebulized lidocaine in the researchers' clinic; it is administered by adding 2% lidocaine + physiological saline to a nebulizer and inhaling for 3-5 minutes in the presence of 4-6 liters/minute of oxygen.
Preoperative examination forms and intraoperative follow-up forms of the patients included in the study will be examined by the researchers. The dose of lidocaine applied and the method of administration will be recorded. In addition, the agents used in anesthesia induction (fentanyl, propofol, rocuronium bromide, etc.) and the hemodynamic changes of the patients (heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure,oxygen saturation) will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine | – | Drug: Iv LidocainePatients who received lidocaine intravenously before induction of anesthesia will be considered in this group. |
| Nebulized lidocaine | – | Drug: Nebulized LidocainePatients who received lidocaine by inhalation with a nebulizer before induction of anesthesia will be considered in this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 80 patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia in the operating room will be included in the study.
Key inclusion criteria (1 listed)
- Patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia
Key exclusion criteria (2 listed)
- Patients under the age of 18 and over the age of 80
- Patients who are not operated under general anesthesia
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 |
|---|---|---|
| Nebulized LidocaineBefore induction of anesthesia, 2% lidocaine + physiological saline was added to a nebulizer and inhaled for 3-5 minutes in the presence of 4-6 liters/minute of oxygen. | Drug | Nebulized lidocaine |
| Iv LidocaineIntravenous %2 lidocaine was administered before induction of anesthesia. | Drug | Intravenous lidocaine |
Primary outcome
Heart Rate
Time frame: Just before induction of anesthesia
Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)
Heart Rate
Time frame: Immediately after induction of anesthesia
Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)
Heart Rate
Time frame: 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
Patients were monitored with a three-lead ECG in the operating room and their heart rates were recorded as beats per minute. (.../min)
Blood Pressure
Time frame: Just before induction of anesthesia
The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.
Blood Pressure
Time frame: Immediately after induction of anesthesia
The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.
Blood Pressure
Time frame: 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
The patients were monitored in the operating room by wearing a noninvasive blood pressure cuff and measurements were taken at 5-minute intervals. Systolic blood pressure, diastolic blood pressure and mean arterial pressure were recorded in mmHg.
Oxygen Saturation
Time frame: Just before induction of anesthesia
The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.
Oxygen Saturation
Time frame: Immediately after induction of anesthesia
The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.
Oxygen Saturation
Time frame: 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded.
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 25 Jun 2024.
- Results publication: PubMed 15815458Baronia AK, Singh PK, Maheshwari A, Jain VK, Mittal P, Pant KC. Inhaled lidocaine for prevention of hemodynamic changes in laryngoscopy and intubation. J Neurosurg Anesthesiol. 1992 Jul;4(3):154-9. doi: 10.1097/00008506-199207000-00002.
- Results publication: PubMed 1389192Sklar BZ, Lurie S, Ezri T, Krichelli D, Savir I, Soroker D. Lidocaine inhalation attenuates the circulatory response to laryngoscopy and endotracheal intubation. J Clin Anesth. 1992 Sep-Oct;4(5):382-5. doi: 10.1016/0952-8180(92)90160-3.
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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?
An observational study of Lidocaine, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 2 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 25 Jun 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Heart Rate (time frame: Just before induction of anesthesia). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06107543, which also lists 2 linked publications.
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 25 Jun 2024.