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The aim of the induction is to decrease stress response of endotracheal intubation. It is also important 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, it is significant 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.
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. Patients scheduled to accept cardiac surgery often have severe concomitant disease. Hemodynamic fluctuation might lead to disastrous events. Anesthesia induction for such patients should not only provide adequate depth of anesthesia to decrease the stress response of endotracheal intubation, but also make hemodynamics stable after tracheal intubation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The combined topical anesthesia induction group | Experimental | The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia，3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia. |
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| The routine induction group | No Intervention | The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia.In the routine induction group，all procedures will be the same as those of the topical anesthesia group, The drug will be replaced with constant volume saline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The combined topical anesthesia induction group | Procedure | The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia，3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve of baseline blood pressure | The area under the curve (AUC) of blood pressure below baseline from the beginning of general anesthesia induction to the surgery beginning. | From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours. |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency and types of vasoactive drugs used. | The frequency and types of vasoactive drugs used ,such as the use of norepinephrine and dopamine. | From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meng Lv, doctor | Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meng-Lv | Jinan | Shandong | 250000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35078841 | Derived | Chen TT, Lv M, Wang JH, Wei CS, Gu CP, Wang YL. Addition of topical airway anaesthesia to conventional induction techniques to reduce haemodynamic instability during the induction period in patients undergoing cardiac surgery: protocol for a randomised controlled study. BMJ Open. 2022 Jan 25;12(1):e053337. doi: 10.1136/bmjopen-2021-053337. |
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|
| The incidence of arrhythmias. | The incidence of arrhythmias, such as atrioventricular block, atrial fibrillation, ventricular tachycardia and so on. | From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours. |
| cardiac systolic function:Left Ventricular Ejection Fraction (LVEF) | Left ventricular ejection fraction is a reliable indicator of left ventricular systolic function. left ventricular ejection fraction (LVEF) (﹪)= stroke output (SV)/ left ventricular end-diastolic volume (LEDV)×100﹪ | Preoperative, intraoperative |
| 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 indicators for evaluating diastolic function, indicated normal diastolic function when E/A >1, and decreased diastolic function when E/A < 1. | Preoperative, intraoperative |
| cardiac output monitoring indicator: CO(cardiac output) | CO＝Stroke Output (SV)× Heart Rate (HR).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences. | Intraoperative |
| cardiac output monitoring indicator: SVV(stroke volume variation) | The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences. | Intraoperative |
| cardiac output monitoring indicator: CI(cardiac index) | CI＝CO/ Body Surface Area (BSA).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences. | Intraoperative |
| cardiac output monitoring indicator: SVR (systemic vascular resistance) | SVR＝60×(MAP-CVP)/CO. MAP: mean arterial pressure. CVP: central venous pressure.The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences. | Intraoperative |
| 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. | Three days after the surgery |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D006349 | Heart Valve Diseases |
| D001145 | Arrhythmias, Cardiac |
| D009202 | Cardiomyopathies |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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