Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-25 @ 7:09 PM
Study NCT ID:
NCT06226532
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-26
First Post:
2024-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation
Sponsor:
Khon Kaen University
Organization:
Study Overview
Official Title:
Effect of Lidocaine Sprayed at the Laryngeal Inlet and Endotracheal Tube Cuff Versus Intravenous Lidocaine for Attenuating Hemodynamic Response During Laryngoscopy and Intubation in Neurosurgical Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to to evaluate the efficacy of lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff compare with intravenous lidocaine on the hemodynamic response to laryngoscopy and intubation in patients undergoing elective neurological procedures during general anesthesia with total intravenous technique.
The main question it aims to answer is:
\- Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique?
Participants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.
The main question it aims to answer is:
\- Does topical lidocaine sprayed at the laryngeal inlet combined with the endotracheal tube cuff have more effect on stabilizing hemodynamic responses to laryngoscopy and intubation than intravenous lidocaine, in neurosurgical patients who undergo general anesthesia with total intravenous technique?
Participants will be recruited and randomized to receive either lidocaine spray (Group SL) or intravenous lidocaine (group IL) to blunt hemodynamic response to laryngoscopy and intubation.
Detailed Description:
Anesthetic protocol
* Preoperative
* After the informed consent, all eligible patients will be fasting after midnight as it is an elective procedure.
* No preoperative sedatives or analgesics were administered.
* Intraoperative Pre-induction phase
* Standard monitors of electrocardiogram, noninvasive blood pressure (NIBP) is measured at upper extremity with BP cuff bladder length ≥ 80% and width ≥40% of patient's arm circumference and pulse oximeter were attached.
* BIS (Bispectral index) was monitored
* Hemodynamic baseline values of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before the induction.
Intervention: prepared before induction anesthesia.
* Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg).
* Group IL: 2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
Induction phase
* Preoxygenation 100% oxygen, flow 6 liters per minute, for 3-5 minutes, target end tidal oxygen more than 90%
* Medication before the induction of anesthesia includes fentanyl 1.5 mcg/kg IV.
* General anesthesia will be induced with propofol target-controlled infusion (TCI) 4-6 mcg/ml IV, followed by cisatracurium 0.15 mg/kg IV for intubation.
* Bag mask ventilation will be started.
* The arterial line will be canulated before direct laryngoscopy and intubation and arterial line pressure transducer will be levelled at the phlebostatic axis and calibrate with NIBP.
* Intervention: Group IL: 2% lidocaine 1.5 mg/kg IV was given 2 minutes after cisatracurium injection.
* Direct laryngoscopy and tracheal intubation were done by an anesthesiologist, 1st (6 months experience), 2nd, and 3rd years anesthesiology resident.
At 5 minutes after cisatracurium injection, direct laryngoscopy will be performed, and spray 10%lidocaine directly to the epiglottis for 4 puffs for SL group.
* Tracheal intubation will be performed.
* The bispectral index (BIS) target range during intubation is 40 to 60.
* The hemodynamic parameters including mean arterial pressure(MAP) in mmHg, systolic blood pressure(SBP) in mmHg, diastolic blood pressure(DBP) in mmHg and heart rate(HR) in beats per minutes(bpm) and BIS will record during the peri-intubation period
All the adverse events (cough, pulmonary aspiration, desaturation, hypotension, hypertension, tachycardia, bradycardia, and arrythmia) will be noted as yes or no.
* Preoperative
* After the informed consent, all eligible patients will be fasting after midnight as it is an elective procedure.
* No preoperative sedatives or analgesics were administered.
* Intraoperative Pre-induction phase
* Standard monitors of electrocardiogram, noninvasive blood pressure (NIBP) is measured at upper extremity with BP cuff bladder length ≥ 80% and width ≥40% of patient's arm circumference and pulse oximeter were attached.
* BIS (Bispectral index) was monitored
* Hemodynamic baseline values of heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded before the induction.
Intervention: prepared before induction anesthesia.
* Group SL: Spray 10% lidocaine for 4 puffs at the endotracheal tube cuff, also prepare for spray at the laryngeal inlet for 4 puffs (total approximately 1.5mg/kg).
* Group IL: 2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
Induction phase
* Preoxygenation 100% oxygen, flow 6 liters per minute, for 3-5 minutes, target end tidal oxygen more than 90%
* Medication before the induction of anesthesia includes fentanyl 1.5 mcg/kg IV.
* General anesthesia will be induced with propofol target-controlled infusion (TCI) 4-6 mcg/ml IV, followed by cisatracurium 0.15 mg/kg IV for intubation.
* Bag mask ventilation will be started.
* The arterial line will be canulated before direct laryngoscopy and intubation and arterial line pressure transducer will be levelled at the phlebostatic axis and calibrate with NIBP.
* Intervention: Group IL: 2% lidocaine 1.5 mg/kg IV was given 2 minutes after cisatracurium injection.
* Direct laryngoscopy and tracheal intubation were done by an anesthesiologist, 1st (6 months experience), 2nd, and 3rd years anesthesiology resident.
At 5 minutes after cisatracurium injection, direct laryngoscopy will be performed, and spray 10%lidocaine directly to the epiglottis for 4 puffs for SL group.
* Tracheal intubation will be performed.
* The bispectral index (BIS) target range during intubation is 40 to 60.
* The hemodynamic parameters including mean arterial pressure(MAP) in mmHg, systolic blood pressure(SBP) in mmHg, diastolic blood pressure(DBP) in mmHg and heart rate(HR) in beats per minutes(bpm) and BIS will record during the peri-intubation period
All the adverse events (cough, pulmonary aspiration, desaturation, hypotension, hypertension, tachycardia, bradycardia, and arrythmia) will be noted as yes or no.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: