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

Effect of Topical Anesthesia Combined With Intravenous Induction on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery: a Randomized Controlled Study

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.

Study Overview

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

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 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 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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.
NO_INTERVENTION: The routine 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.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.

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 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.

Secondary Outcome Measures

Outcome Measure	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.
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

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2021
• Primary Completion (ACTUAL): April 27, 2021
• Study Completion (ACTUAL): April 27, 2022

Study Registration Dates

• First Submitted: January 24, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (ACTUAL): February 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

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

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