Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation
Condition: Cardiovascular Diseases; Lidocaine Causing Adverse Effects in Therapeutic Use; Tracheal Intubation Morbidity
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      In patients undergoing coronary bypass surgery; 10% topical lidocaine administered
      endotracheally before intubation is to investigate the effect of hemodynamic response and EKG
      paramater after intubation.
    

Detailed description: 
      This prospective randomized double-blind study consisted of 60 volunteers undergoing coronary
      artery bypass surgery. Patients will be randomized and divided into two groups as control
      (Group C) = 30) and topical lidocaine group (Group L) = 30). Two intravenous 18-gauge (G)
      cannula will be inserted to all patients. Premedication will be provided with 0.03 mg/kg
      intravenous (iv) midazolam (Dormicum 1 mg/ml, Roche preparations Inc., Istanbul Turkey) and
      50 mcg fentanyl and patients will be given 2 L / min O2 via nasal cannula. Radial artery
      cannulation will be performed by applying an Allen Test with 20G cannula under topical
      anesthesia. heart rate (HR), mean arterial pressure (MAB), peripheral oxygen saturation
      (SpO2) will be recorded. Induction of group C will be performed after preoperative
      preparation. No intervention will be made in group c and standard anesthesia protocol will be
      applied.

      Group L (intervention group) Oral-tracheal lidocaine spray will be applied. The induction of
      group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine
      pump spray 10% 50 ml) 160 mg (16 puffs) . After pre-oxygenation, anesthesia induction will be
      performed with intravenous administration of 2 μg / kg fentanyl, 2 mg/kg propofol, 0.6 mg/kg
      rocuronium bromide (Esmeron 5 mg vial, Organon Oss Holanda). Tracheal intubation of all
      patients will be performed by an experienced anesthesiologist after providing adequate
      relaxation. Anesthesia will be maintained with sevoflurane(Forane, Abbott, İstanbul Türkiye)
      % 2 in a 50% Air +50% O2 mixture. ECG recording of participants will be performed before
      (baseline) and after one minute from induction and at the first and third minutes following
      intubation. Hemodynamic measurements and record (MAB, HR, SpO2) will be performed at baseline
      one minute after the induction of anesthesia as well as at 1,3,5,10 min after tracheal
      intubation. Before the ECG analysis, all participants will be blinded by closing their group
      names on the ECG recording. QTc (corrected QT,), QT intarvale dispersion (QTd), P wave
      dispersion will calculated by a blind researcher within a 12-lead ECG recording (velocity: 25
      mm / sec, Amplitude: 10 mm / mV). QTd , was the difference between the longest QT
      intervale(QT max.) durations and shortest QT intervale(QT min.) durations(msec); P wave
      dispersion, was the difference between the longest and shortest P-wave durations(msec); QTc
      interval was calculated using Bazett's formula (QTc = QT/√RR).)
    

Intervention name(s): Orotracheal Lidocaine Oral Spray application
Intervention type(s): Drug
Intervention description(s): The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine pump spray 10% 50 ml) 160 mg (16 puffs) application
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Vemcaine pump spray 10% 50 ml) 160 mg (16 puffs).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: QT dispersion; topical lidocaine; P-wave values