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

NCT03304431 | Completed Phase 4

• 1 other identifier: AbantIBU mb5
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

QT dispersion; topical lidocaine; P-wave values

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• hemodynamic response

  baseline, after anesthesia induction one minute, after tracheal intubation 1 minute, 3 minute, 5 minute, 10 minute

• hemodynamic response

  baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute

Study Arms (2)

Control group(Group C)

NO INTERVENTION

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

OTHER

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

Interventions

Orotracheal Lidocaine Oral Spray application DRUG

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

Group L

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between age patients
• ASA status III patients
• patients undergoing coronary artery bypass graft operation

You may not qualify if:

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

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University Medical School,

Bolu, 14280, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 23683444 RESULT

• 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.

  PMID: 32549100 DERIVED

Related Links

• pubmed

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• murat bilgi

  Abant Izzet Baysal University Medical School, Bolu, TURKEY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: QTc (corrected QT), QT dispersion (QTd), P wave dispersion will calculated by a blind researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: October 9, 2017
• Study Start: May 26, 2017
• Primary Completion: August 20, 2017
• Study Completion: September 20, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)