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

Sponsor

Qianfoshan Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05323786

Collaborator

(none)

Enrollment

Location

Arms

8.6

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Valvular Heart Disease Arrythmia	Procedure: The combined topical anesthesia induction group Procedure: The routine induction group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 20, 2022

Anticipated Primary Completion Date :

Dec 8, 2022

Anticipated Study Completion Date :

Jan 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: The combined topical anesthesia induction group 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 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.
Placebo Comparator: The routine induction group 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 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.

Arm

Intervention/Treatment

Experimental: The combined topical anesthesia induction group

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

Placebo Comparator: The routine induction group

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

Outcome Measures

Primary Outcome Measures

The area under the curve of baseline blood pressure [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.]
The area under the curve (AUC) of blood pressure below baseline mean arterial pressure within 3 minutes to 15 minutes after endotracheal intubation

Secondary Outcome Measures

The area under the curve of baseline blood pressure [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.]
AUC above baseline MAP (MAP-time integral) and below baseline MAP (MAP-time integral)
The highest and lowest values of arterial blood pressure [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 highest and lowest values of arterial blood pressure (SBP, DBP, MAP)
The types of vasoactive drugs used. [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 ,such as the use of norepinephrine and dopamine.
The frequency of vasoactive drugs used. [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 ,such as the use of norepinephrine and dopamine.
The incidence of arrhythmias. [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, such as atrioventricular block, atrial fibrillation, ventricular tachycardia and so on.
cardiac systolic function:Left Ventricular Ejection Fraction (LVEF) [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.]
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.
cardiac diastolic function:E/E' (the ratio of E peak and E') or E/A :(the ratio of E peak and A peak) [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.]
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).
tricuspid annular plane systolic excursion(TAPSE) [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 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).
Respiratory variation in inferior vena cava diameter (DIVC) [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) 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
The number of patients with postoperative hoarseness. [Three days after the surgery]
Hoarseness was classified as mild, moderate and severe according to the severity.
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(0-10 score, 0: no pain, 10: worst imaginable pain).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.