A Phase 4 interventional study of Orotracheal Lidocaine Oral Spray application in Cardiovascular Diseases, Lidocaine Causing Adverse Effects in Therapeutic Use and Tracheal Intubation Morbidity, sponsored by Abant Izzet Baysal University. Completed at 1 site in Turkey. Open to participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-09.
Sponsored by Abant Izzet Baysal University · Phase 4, Interventional, and Treatment
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.
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).)
Exclusion Criteria:
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).
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
Drug: Orotracheal Lidocaine Oral Spray application
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
ECG parameter
P wave dispersion was the difference between the longest and shortest P-wave durations (msec); )
Time frame: baseline, one minute from induction,first and third minutes following intubation
hemodynamic response
heart rate (beats / minute)
Time frame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute, 3 minute, 5 minute, 10 minute
hemodynamic response
mean arterial pressure(mmHg)
Time frame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute
Plan to share: No
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Abant Izzet Baysal University