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

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

Tracking Information
First Submitted Date  ICMJE August 7, 2017
First Posted Date  ICMJE October 9, 2017
Last Update Posted Date October 9, 2017
Actual Study Start Date  ICMJE May 26, 2017
Actual Primary Completion Date August 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
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); )
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Effect of 10% Lidocaine Spray Undergoing Coronary Artery Bypass Graft Operation
Official Title  ICMJE 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
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).)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Cardiovascular Diseases
  • Lidocaine Causing Adverse Effects in Therapeutic Use
  • Tracheal Intubation Morbidity
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: Orotracheal Lidocaine Oral Spray application
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2017)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 20, 2017
Actual Primary Completion Date August 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03304431
Other Study ID Numbers  ICMJE AbantIBU mb5
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abant Izzet Baysal University
Study Sponsor  ICMJE Abant Izzet Baysal University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: murat bilgi Abant Izzet Baysal University Medical School, Bolu, TURKEY
PRS Account Abant Izzet Baysal University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP