Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06226532
Study type Interventional
Source Khon Kaen University
Contact Nattawadee Phokaw, MD
Phone +66619719493
Email Nattapho@kku.ac.th
Status Not yet recruiting
Phase Phase 4
Start date January 2024
Completion date May 2025

See also
  Status Clinical Trial Phase
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Suspended NCT04253795 - Nonintubated Versus Intubated Anesthesia in Video-assisted Thoracic Surgery N/A
Completed NCT02864017 - Immuno Nutrition by L-citrulline for Critically Ill Patients N/A
Completed NCT02900807 - CT-scan Airways Mensuration - Correlation to External Measurements
Completed NCT01823328 - Ketamine Versus Etomidate for Rapid Sequence Intubation Phase 4
Completed NCT02350933 - Endoscopic Evaluation of the Paediatric Airway After Prior Prolonged (>24 h) Tracheal Intubation N/A
Completed NCT01170455 - Nasal Intubation Using the Blind Intubation Device N/A
Completed NCT00980590 - Airway Scope and Macintosh Laryngoscope for Tracheal Intubation in Patients Lying on the Ground N/A
Completed NCT05515107 - The Laryngoscopic View With C-MAC Videolaryngoscope Miller Blade Lifting the Epiglottis or the Vallecula in Children N/A
Completed NCT06249659 - Impact of Extubation Location After Surgery on Perioperative Times
Completed NCT03677505 - KoMAC Videolaryngoscope for Double-lumen Intubation N/A
Completed NCT03328182 - Assessment of an Oral Endotracheal Subglottic Tube Holder N/A
Recruiting NCT02277405 - Pediatric Intubation During Resuscitation N/A
Recruiting NCT02277652 - Endotracheal Intubation Devices N/A
Recruiting NCT02073786 - Rigid Video Stylet Vs Conventional Lightwand Intubation N/A
Completed NCT02277418 - Venner a.p. Advance Video Laryngoscope N/A
Completed NCT01003327 - Comparison of the I-gel Laryngeal Mask and the Classic Laryngeal Mask in Patients With a BMI>25 Phase 4
Completed NCT00956592 - Clinical Evaluation of the Storz CMAC Laryngoscope N/A
Completed NCT00783731 - Low Dose of Midazolam is Superior to Conventional Dose for Rapid Sequence Intubation in Emergency Department (ED) N/A
Recruiting NCT03887897 - First Attempt Intubation Rate With Airtraq vs Macintosh Direct Laryngoscope N/A