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

• ClinicalTrials.gov Identifier: NCT03304431
• Recruitment Status: Completed
• First Posted: October 9, 2017
• Last Update Posted: October 9, 2017
• Sponsor: Abant Izzet Baysal University
• Information provided by (Responsible Party): Abant Izzet Baysal University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Lidocaine Causing Adverse Effects in Therapeutic Use; Tracheal Intubation Morbidity	Drug: Orotracheal Lidocaine Oral Spray application	Phase 4

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).)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• 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)
• Masking Description: QTc (corrected QT), QT dispersion (QTd), P wave dispersion will calculated by a blind researcher.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 26, 2017
• Actual Primary Completion Date: August 20, 2017
• Actual Study Completion Date: September 20, 2017

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control group(Group C); 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).
Group L; 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

Outcome Measures

Primary Outcome Measures :

1. ECG parameter [ Time Frame: baseline, one minute from induction,first and third minutes following intubation ]
   P wave dispersion was the difference between the longest and shortest P-wave durations (msec); )

Secondary Outcome Measures :

1. hemodynamic response [ Time Frame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute, 3 minute, 5 minute, 10 minute ]
   heart rate (beats / minute)
2. hemodynamic response [ Time Frame: baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute ]
   mean arterial pressure(mmHg)

Eligibility Criteria

• Ages Eligible for Study: 50 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Turkey

Abant Izzet Baysal University Medical School,

Bolu, Turkey, 14280

Sponsors and Collaborators

Abant Izzet Baysal University

Investigators

• Principal Investigator: murat bilgi; Abant Izzet Baysal University Medical School, Bolu, TURKEY

More Information

Additional Information:

pubmed 

Publications of Results:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Abant Izzet Baysal University
• ClinicalTrials.gov Identifier: NCT03304431
• Other Study ID Numbers: AbantIBU mb5
• First Posted: October 9, 2017
• Last Update Posted: October 9, 2017
• Last Verified: October 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Abant Izzet Baysal University:

QT dispersion; topical lidocaine; P-wave values

Additional relevant MeSH terms:

Cardiovascular Diseases; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action