Effect of Topical Anesthesia on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery.

Not Applicable

Completed

• Conditions: Valvular Heart Disease; Myocardial Disease; Arrhythmia; Coronary Artery Disease
• Interventions: Procedure: The combined topical anesthesia induction group

• Registration Number: NCT04744480
• Lead Sponsor: Qianfoshan Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-01-24
• Study First Submitted QC: 2021-02-03
• Study First Posted: 2021-02-09
• Study Start: 2021-03-05
• Primary Completion: 2021-04-27
• Study Completion: 2022-04-27
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-28
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Patients scheduled to accept elective /major cardiac surgery;
2. Patients older than 18 years and younger than 85 years;
3. Patients of The American Society of Anesthesiologists ( ASA )Ⅱ - Ⅳ level grade;
4. Patients signed the informed consent form for the clinical study;

Exclusion Criteria

1. Patients cannot cooperate to topical anesthesia;
2. Patients with a left cardiac assist device prior to surgery;
3. Patients with aortic dissection;
4. Patients with Intra Aortic Balloon Pump (IABP) prior to surgery;
5. Patients treated with Extracorporeal Membrane Oxygenation (ECMO) prior to surgery;
6. Patients with difficult airway;
7. Patients with high sensitivity and hypersensitivity to lidocaine and tetracaine;
8. Patients with atrioventricular block;
9. Hemoglobin(Hb)<80g/L；
10. Patients who have participated in other clinical studies during the last 3 months;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The combined topical anesthesia induction group	The combined topical anesthesia induction group	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.

Primary Outcome Measures

Name	Time	Method
The area under the curve of baseline blood pressure	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.	The area under the curve (AUC) of blood pressure below baseline from the beginning of general anesthesia induction to the surgery beginning.

Secondary Outcome Measures

Name	Time	Method
cardiac systolic function:Left Ventricular Ejection Fraction (LVEF)	Preoperative, intraoperative	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﹪
cardiac diastolic function:E/E' (the ratio of E peak and E') or E/A :(the ratio of E peak and A peak)	Preoperative, intraoperative	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.
cardiac output monitoring indicator: CO(cardiac output)	Intraoperative	CO＝Stroke Output (SV)× Heart Rate (HR).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
The frequency and types of vasoactive drugs used.	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.	The frequency and types of vasoactive drugs used ,such as the use of norepinephrine and dopamine.
The incidence of arrhythmias.	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.	The incidence of arrhythmias, such as atrioventricular block, atrial fibrillation, ventricular tachycardia and so on.
The number of patients with postoperative sore throat.	Three days after the surgery	Sore throats can be evaluated using the Numeric Pain Scale (NRS) pain numerical score.
cardiac output monitoring indicator: SVV(stroke volume variation)	Intraoperative	The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
cardiac output monitoring indicator: CI(cardiac index)	Intraoperative	CI＝CO/ Body Surface Area (BSA).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
cardiac output monitoring indicator: SVR (systemic vascular resistance)	Intraoperative	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.
The number of patients with postoperative hoarseness.	Three days after the surgery	Hoarseness was classified as mild, moderate and severe according to the severity.

Trial Locations

Locations (1)

Meng-Lv; 🇨🇳 Jinan, Shandong, China