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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Valvular Heart Disease; Arrythmia
• Intervention / Treatment: Procedure: The combined topical anesthesia induction group; Procedure: The routine induction group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Meng-Lv

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients older than 18 years and younger than 75 years;
2. Patients scheduled to accept elective cardiac surgery;
3. Patients of New York Heart Association (NYHA) Ⅱ～Ⅲ level grade ;
4. Patients signed the informed consent form for the clinical study.

Exclusion Criteria:

1. Patients cannot cooperate to topical anesthesia;
2. Patients who had left heart assist devices other than intra-aortic balloon counterpulsation before surgery;
3. Patients treated with Extracorporeal Membrane Oxygenation (ECMO) prior to surgery;
4. Patients with aortic dissection;
5. Patients with difficult airway;
6. Patients with high sensitivity and hypersensitivity to lidocaine;
7. Patients with atrioventricular block;
8. Patients who have participated in other clinical studies during the last 3 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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 number of patients with postoperative hoarseness.	Hoarseness was classified as mild, moderate and severe according to the severity.	Three days after the surgery
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 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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Publications and helpful links

General Publications

• Du W, Lv M, Chen T, Sun X, Wang J, Zhang H, Wei C, Liu Y, Qiao C, Wang Y. The effect of topical airway anesthesia on hemodynamic profiles during the induction period in patients undergoing cardiac surgery: Study protocol for a randomized controlled trial. Front Cardiovasc Med. 2022 Oct 10;9:992534. doi: 10.3389/fcvm.2022.992534. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): January 21, 2023

Study Registration Dates

• First Submitted: April 2, 2022
• First Submitted That Met QC Criteria: April 11, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Cardiac surgery; Hemodynamics; Endotracheal intubation; Topical anesthesia; Atomization inhalation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Heart Valve Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: TACTICS-Ⅱ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No