Hemodynamic Effect of Topical Anesthesia During Induction in Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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Patients scheduled for cardiac surgery are fragile. Hemodynamic fluctuation might be associated with adverse outcomes. Therefore, it is essential to keep hemodynamics stable during and after the induction period. Previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can significantly reduce the dosage of intravenous anesthetics. Therefore, we designed this study to explore whether the combination of topical anesthesia and intravenous anesthetics could decrease the stress response of endotracheal intubation and keep hemodynamics stable during and after the induction period.

Detailed Description
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Patients scheduled for cardiac surgery are often accompanied by cardiac insufficiency. Hemodynamic fluctuation might lead to disastrous events. Therefore, it is essential to keep hemodynamics stable during and after the induction period. The routine anesthesia induction strategy for cardiac surgery is to decrease stress response during endotracheal intubation by using large doses of opioids. However, high doses of opioids often leads to persistent and recurrent hypotension in patients from the anesthesia induction period to the beginning of the surgery. Previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can significantly reduce the dosage of intravenous anesthetics. Therefore, we designed this study to explore whether the combination of topical anesthesia and intravenous anesthetics could decrease the stress response of endotracheal intubation and keep hemodynamics stable during and after the induction period.

Official Title
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Effect of Topical Anesthesia on Hemodynamics During Induction in Patients Undergoing Cardiac Surgery: a Randomized Controlled Study

Conditions
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Coronary Artery Disease, Valvular Heart Disease, Arrythmia

Intervention / Treatment
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* Procedure: The combined topical anesthesia induction group
* Procedure: The routine induction group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years and younger than 75 years; Patients scheduled to accept elective cardiac surgery; Patients of New York Heart Association (NYHA) Ⅱ～Ⅲ level grade ; Patients signed the informed consent form for the clinical study. Exclusion Criteria: Patients cannot cooperate to topical anesthesia; Patients who had left heart assist devices other than intra-aortic balloon counterpulsation before surgery; Patients treated with Extracorporeal Membrane Oxygenation (ECMO) prior to surgery; Patients with aortic dissection; Patients with difficult airway; Patients with high sensitivity and hypersensitivity to lidocaine; Patients with atrioventricular block; Patients who have participated in other clinical studies during the last 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The combined topical anesthesia induction group<br>Inhalation of aerosolized surface anesthesia with 10 ml 2% lidocaine would be administered with an atomizer for 15 minutes prior to intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia with 3ml 2% lidocaine. | Procedure: The combined topical anesthesia induction group<br>* Inhalation of aerosolized surface anesthesia with 10 ml 2% lidocaine would be administered with an atomizer for 15 minutes prior to intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia with 3ml 2% lidocaine.<br>|
| Placebo Comparator: The routine induction group<br>Inhalation of 10 ml 0.9% normal saline would be administered with an atomizer for 15 minutes prior to intravenous anesthesia. After the intravenous induction, 3ml 0.9% normal saline would be administered into subglottic airway with a catheter. | Procedure: The routine induction group<br>* Inhalation of 10 ml 0.9% normal saline would be administered with an atomizer for 15 minutes prior to intravenous anesthesia. After the intravenous induction, 3ml 0.9% normal saline would be administered into subglottic airway with a catheter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the curve of baseline blood pressure | The area under the curve (AUC) of blood pressure below baseline mean arterial pressure within 3 minutes to 15 minutes after endotracheal intubation | From 3 minutes after endotracheal intubation(T1) to 15 minutes after endotracheal intubation(T2). T1 is defined as 3 minutes after endotracheal intubation. T2 is defined as 15 minutes after endotracheal intubation. It will take up to 1hour or 2hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the curve of baseline blood pressure | AUC above baseline MAP (MAP-time integral) and below baseline MAP (MAP-time integral) | From from the beginning of the general anaesthesia induction(T1) to 3 minutes after endotracheal intubation(T2). T1 is when midazolam is administered. T2 is defined as 3 minutes after endotracheal intubation. It will take up to 1hour or 2hours. | 
| The highest and lowest values of arterial blood pressure | The highest and lowest values of arterial blood pressure (SBP, DBP, MAP) | From the beginning of the general anaesthesia induction(T1) to 15 minutes after endotracheal intubation(T2). T1 is when midazolam is administered. T2 is defined as 15 minutes after endotracheal intubation. It will take up to 1hour or 2hours. | 
| The types of vasoactive drugs used. | The types of vasoactive drugs used ,such as the use of norepinephrine and dopamine. | From the beginning of the general anaesthesia induction(T1) to 15 minutes after endotracheal intubation(T2). T1 is when midazolam is administered. T2 is defined as 15 minutes after endotracheal intubation. It will take up to 1hour or 2hours. | 
| The frequency of vasoactive drugs used. | The frequency of vasoactive drugs used ,such as the use of norepinephrine and dopamine. | From the beginning of the general anaesthesia induction(T1) to 15 minutes after endotracheal intubation(T2). T1 is when midazolam is administered. T2 is defined as 15 minutes after endotracheal intubation. It will take up to 1hour or 2hours. | 
| The incidence of arrhythmias. | The incidence of arrhythmias, such as atrioventricular block, atrial fibrillation, ventricular tachycardia and so on. | From the beginning of the general anaesthesia induction(T1) to 15 minutes after endotracheal intubation(T2). T1 is when midazolam is administered. T2 is defined as 15 minutes after endotracheal intubation. It will take up to 1hour or 2hours. | 
| cardiac systolic function:Left Ventricular Ejection Fraction (LVEF) | Left ventricular ejection fraction，a parameter of left ventricular systolic function. left ventricular ejection fraction (LVEF) (﹪)= stroke output (SV)/ left ventricular end-diastolic volume (LEDV)×100﹪，will be evaluated before induction of anesthesia and after central venous catheterization. | Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours. | 
| cardiac diastolic function:E/E' (the ratio of E peak and E') or E/A :(the ratio of E peak and A peak) | E/A ratio, one of the main parameter for evaluating diastolic function, indicated normal diastolic function when E/A >1, and decreased diastolic function when E/A < 1.It will be evaluated before induction of anesthesia(T1) and after central venous catheterization(T2). | Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours. | 
| tricuspid annular plane systolic excursion(TAPSE) | Tricuspid annular plane systolic excursion is a reliable indicator of right ventricular systolic function.It represents the longitudinal function of the RV and it should be measured in the apical four-chamber projection using one-dimensional echocardiography (M-mode) at the peak excursion of the tricuspid annulus (expressed in millimeters) from the end of diastole to the end of systole.It will be evaluated before induction of anesthesia(T1) and after central venous catheterization(T2). | Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours. | 
| Respiratory variation in inferior vena cava diameter (DIVC) | Respiratory variation in inferior vena cava diameter (DIVC) is a measure of capacity load.DIVC=(Maximum diameter of inferior vena cava - minimum diameter of inferior vena cava) ÷ maximum diameter of inferior vena cava | Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours. | 
| The number of patients with postoperative hoarseness. | Hoarseness was classified as mild, moderate and severe according to the severity. | Three days after the surgery | 
| The number of patients with postoperative sore throat. | Sore throats can be evaluated using the Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain). | Three days after the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical anesthesia, Atomization inhalation, Cardiac surgery, Hemodynamics, Endotracheal intubation