Effect of Lidocaine Sprayed for Attenuating Hemodynamic Response During Laryngoscopy and Intubation
NCT ID: NCT06226532
Last Updated: 2024-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
50 participants
INTERVENTIONAL
2024-01-31
2025-05-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. Group IL: 2% lidocaine intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.
TREATMENT
DOUBLE
Study Groups
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Group SL
10%lidocaine spray total 8 puffs at laryngoscopes blade and endotracheal tube cuff, 4 puffs each.
lidocaine spray
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 intravenous 1.5 mg/kg, not exceed 80 mg equally to spray group.
Intravenous Lidocaine
2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
Interventions
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lidocaine spray
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)
Intravenous Lidocaine
2% lidocaine 1.5 mg/kg IV will be given 2 minutes after cisatracurium injection (3 minutes prior intubation).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologists (ASA) physical status classification I-II
Exclusion Criteria
2. Predicted difficult airways
3. Body mass index \> 35 kilograms per meter squared
4. Risk aspiration
5. Baseline hemodynamic instability; heart rate \< 50 bpm, heart rate \> 120 bpm, blood pressure \< 90/60 mmHg, blood pressure \> 160/90 mmHg
6. Underlying disease: epilepsy, cardiovascular disease, heart failure, impaired cardiac function, severe renal dysfunction, impaired hepatic function, peripheral vascular disease
7. Pregnancy
8. Cerebral aneurysm, Arteriovenous malformation, Tumor size \> 4 centimeters, Brain herniation
18 Years
65 Years
ALL
Yes
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Nattawadee Phokaw, MD
Principal investigator
Principal Investigators
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Nattawadee Phokaw, MD
Role: PRINCIPAL_INVESTIGATOR
Department of anesthesiologist, Faculty of Medicine, Khon Kaen University
Locations
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Khon Kaen University
Nai Muang, KhonKaen, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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Ismail SA, Bisher NA, Kandil HW, Mowafi HA, Atawia HA. Intraocular pressure and haemodynamic responses to insertion of the i-gel, laryngeal mask airway or endotracheal tube. Eur J Anaesthesiol. 2011 Jun;28(6):443-8. doi: 10.1097/EJA.0b013e328345a413.
Basali A, Mascha EJ, Kalfas I, Schubert A. Relation between perioperative hypertension and intracranial hemorrhage after craniotomy. Anesthesiology. 2000 Jul;93(1):48-54. doi: 10.1097/00000542-200007000-00012.
Tada Y, Wada K, Shimada K, Makino H, Liang EI, Murakami S, Kudo M, Kitazato KT, Nagahiro S, Hashimoto T. Roles of hypertension in the rupture of intracranial aneurysms. Stroke. 2014 Feb;45(2):579-86. doi: 10.1161/STROKEAHA.113.003072. Epub 2013 Dec 26.
Khan FA, Ullah H. Pharmacological agents for preventing morbidity associated with the haemodynamic response to tracheal intubation. Cochrane Database Syst Rev. 2013 Jul 3;2013(7):CD004087. doi: 10.1002/14651858.CD004087.pub2.
Gerlach AT, Murphy CV. Dexmedetomidine-associated bradycardia progressing to pulseless electrical activity: case report and review of the literature. Pharmacotherapy. 2009 Dec;29(12):1492. doi: 10.1592/phco.29.12.1492.
Tam S, Chung F, Campbell M. Intravenous lidocaine: optimal time of injection before tracheal intubation. Anesth Analg. 1987 Oct;66(10):1036-8. No abstract available.
Shribman AJ, Smith G, Achola KJ. Cardiovascular and catecholamine responses to laryngoscopy with and without tracheal intubation. Br J Anaesth. 1987 Mar;59(3):295-9. doi: 10.1093/bja/59.3.295.
Lee SY, Min JJ, Kim HJ, Hong DM, Kim HJ, Park HP. Hemodynamic effects of topical lidocaine on the laryngoscope blade and trachea during endotracheal intubation: a prospective, double-blind, randomized study. J Anesth. 2014 Oct;28(5):668-75. doi: 10.1007/s00540-014-1812-z. Epub 2014 Mar 12.
Other Identifiers
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HE661362
Identifier Type: -
Identifier Source: org_study_id
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