Clinical trial NCT03304431: Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation
Official title: Evaluation of the Effect of 10% Lidocaine Spray on Hemodynamic Response and EKG Parameter Performed Before Endotracheal Intubation in Patients Undergoing Coronary Artery Bypass Graft Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiovascular Diseases
Lidocaine Causing Adverse Effects in Therapeutic Use
Tracheal Intubation Morbidity
Keywords: QT dispersion
topical lidocaine
P-wave values
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

Brief 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).)

Eligibility criteria: Inclusion Criteria:

* 50-75 between age patients
* ASA status III patients
* patients undergoing coronary artery bypass graft operation

Exclusion Criteria:

* cardiomyopathy,
* arrhythmia,
* valvular disease,
* electrolyte disorders
* chronic liver and kidney diseases
* use of medication that led to extended QT intervals

Primary outcomes:
measure: ECG parameter
timeFrame: baseline, one minute from induction,first and third minutes following intubation
Secondary outcomes:
measure: hemodynamic response
timeFrame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute, 3 minute, 5 minute, 10 minute
measure: hemodynamic response
timeFrame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University Medical School,
Study officials:
affiliation: Abant Izzet Baysal University Medical School, Bolu, TURKEY
name: murat bilgi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanci V, Yurtlu S, Karabag T, Okyay D, Hakimoglu S, Kayhan G, Buyukuysal C, Ayoglu H, Ozkocak Turan I. Effects of esmolol, lidocaine and fentanyl on P wave dispersion, QT, QTc intervals and hemodynamic responses to endotracheal intubation during propofol induction: a comparative study. Braz J Anesthesiol. 2013 May-Jun;63(3):235-44. doi: 10.1016/S0034-7094(13)70223-X. English, Portuguese, Spanish.
citation: Bilgi M, Velioglu Y, Yoldas H, Cosgun M, Yuksel A, Karagoz I, Yildiz I, Es A, Caliskan D, Erdem K, Demirhan A. Effects of Lidocaine Oropharyngeal Spray Applied Before Endotracheal Intubation on QT Dispersion in Patients Undergoing Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Study. Braz J Cardiovasc Surg. 2020 Jun 1;35(3):291-298. doi: 10.21470/1678-9741-2019-0112.