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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06107543
Other study ID # DerinceTRH-EAtli-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date July 1, 2024

Study information

Verified date April 2024
Source Derince Training and Research Hospital
Contact Emine Atli
Phone +905388442699
Email dr.emineatli@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Nebulized Lidocaine
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 Lidocaine
Intravenous %2 lidocaine was administered before induction of anesthesia.

Locations

Country Name City State
Turkey Derince Training and Research Hospital Kocaeli

Sponsors (1)

Lead Sponsor Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) Just before induction of anesthesia
Primary 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) Immediately after induction of anesthesia
Primary 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) 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
Primary 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. Just before induction of anesthesia
Primary 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. Immediately after induction of anesthesia
Primary 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. 5 minutes and 10 minutes after direct laryngoscopy and endotracheal intubation
Primary Oxygen Saturation The patients were monitored with a pulse oximetry device in the operating room and their oxygen saturation % (spO2) was recorded. Just before induction of anesthesia
Primary Oxygen Saturation 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
Primary Oxygen Saturation 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
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