- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06107543
Lidocaine in the Prevention of Hemodynamic Response to Laryngoscopy and Endotracheal Intubation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emine Atlı
- Phone Number: +905388442699
- Email: dr.emineatli@gmail.com
Study Contact Backup
- Name: Mehmet Yılmaz
- Phone Number: +905052174432
- Email: drmyilmaz33@gmail.com
Study Locations
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-
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Kocaeli, Turkey, 41900
- Recruiting
- Derince Training and Research Hospital
-
Contact:
- Mehmet Yılmaz
- Phone Number: +905052174432
- Email: drmyilmaz33@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over the age of 18 and under the age of 80 who underwent surgery under general anesthesia
Exclusion Criteria:
- Patients under the age of 18 and over the age of 80
- Patients who are not operated under general anesthesia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Intravenous lidocaine
Patients who received lidocaine intravenously before induction of anesthesia will be considered in this group.
|
Intravenous %2 lidocaine was administered before induction of anesthesia.
|
Nebulized lidocaine
Patients who received lidocaine by inhalation with a nebulizer before induction of anesthesia will be considered in this group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Just before induction of anesthesia
|
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)
|
Immediately after induction of anesthesia
|
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)
|
5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
|
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.
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Just before induction of anesthesia
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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.
|
Immediately after induction of anesthesia
|
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.
|
5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
|
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.
|
Just before induction of anesthesia
|
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.
|
Immediately after induction of anesthesia
|
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.
|
5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Sklar 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- DerinceTRH-EAtli-001
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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