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临床试验/NCT03304431
NCT03304431已完成4 期

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

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年5月26日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
ECG parameter

研究概览

简要总结

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.

详细描述

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).)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

QTc (corrected QT), QT dispersion (QTd), P wave dispersion will calculated by a blind researcher.

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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

干预措施: Orotracheal Lidocaine Oral Spray application (Drug)

结局指标

主要结局

ECG parameter

时间窗: 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); )

次要结局

  • hemodynamic response(baseline, after anesthesia induction one minute, after tracheal intubation 1 minute,3 minute, 5 minute, 10 minute)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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