Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation

Cardiovascular Diseases Clinical Trial

— ELCABG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03304431
• Other study ID #: AbantIBU mb5
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2017
• Last updated: October 6, 2017
• Start date: May 26, 2017
• Est. completion date: September 20, 2017

Study information

• Verified date: October 2017
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 20, 2017
• Est. primary completion date: August 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Lidocaine Causing Adverse Effects in Therapeutic Use
• Tracheal Intubation Morbidity

Intervention

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

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University Medical School,	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Hanci V, Yurtlu S, Karabag T, Okyay D, Hakimoglu S, Kayhan G, Büyükuysal Ç, Ayoglu H, Özkoçak Turan I. Effects of esmolol, lidocaine and fentanyl on P wave dispersion, QT, QTc intervals and hemodynamic responses to endotracheal intubation during propofol — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECG parameter	P wave dispersion was the difference between the longest and shortest P-wave durations (msec); )	baseline, one minute from induction,first and third minutes following intubation
Secondary	hemodynamic response	heart rate (beats / minute)	baseline, after anesthesia induction one minute, after tracheal intubation 1 minute, 3 minute, 5 minute, 10 minute
Secondary	hemodynamic response	mean arterial pressure(mmHg)	baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute

External Links

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