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

Primary Purpose

Coronary Artery Disease, Valvular Heart Disease, Arrythmia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The combined topical anesthesia induction group
The routine induction group
Sponsored by
Qianfoshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring Topical anesthesia, Atomization inhalation, Cardiac surgery, Hemodynamics, Endotracheal intubation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Meng-Lv

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The combined topical anesthesia induction group

The routine induction group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The area under the curve of baseline blood pressure
AUC above baseline MAP (MAP-time integral) and below baseline MAP (MAP-time integral)
The highest and lowest values of arterial blood pressure
The highest and lowest values of arterial blood pressure (SBP, DBP, MAP)
The types of vasoactive drugs used.
The types of vasoactive drugs used ,such as the use of norepinephrine and dopamine.
The frequency of vasoactive drugs used.
The frequency of vasoactive drugs used ,such as the use of norepinephrine and dopamine.
The incidence of arrhythmias.
The incidence of arrhythmias, such as atrioventricular block, atrial fibrillation, ventricular tachycardia and so on.
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.
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).
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).
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
The number of patients with postoperative hoarseness.
Hoarseness was classified as mild, moderate and severe according to the severity.
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).

Full Information

First Posted
April 2, 2022
Last Updated
April 2, 2023
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05323786
Brief Title
Hemodynamic Effect of Topical Anesthesia During Induction in Patients Undergoing Cardiac Surgery
Official Title
Effect of Topical Anesthesia on Hemodynamics During Induction in Patients Undergoing Cardiac Surgery: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qianfoshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Valvular Heart Disease, Arrythmia
Keywords
Topical anesthesia, Atomization inhalation, Cardiac surgery, Hemodynamics, Endotracheal intubation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The combined topical anesthesia induction group
Arm Type
Experimental
Arm Description
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.
Arm Title
The routine induction group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
The combined topical anesthesia induction group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
The routine induction group
Intervention Description
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.
Primary Outcome Measure Information:
Title
The area under the curve of baseline blood pressure
Description
The area under the curve (AUC) of blood pressure below baseline mean arterial pressure within 3 minutes to 15 minutes after endotracheal intubation
Time Frame
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 Measure Information:
Title
The area under the curve of baseline blood pressure
Description
AUC above baseline MAP (MAP-time integral) and below baseline MAP (MAP-time integral)
Time Frame
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.
Title
The highest and lowest values of arterial blood pressure
Description
The highest and lowest values of arterial blood pressure (SBP, DBP, MAP)
Time Frame
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.
Title
The types of vasoactive drugs used.
Description
The types of vasoactive drugs used ,such as the use of norepinephrine and dopamine.
Time Frame
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.
Title
The frequency of vasoactive drugs used.
Description
The frequency of vasoactive drugs used ,such as the use of norepinephrine and dopamine.
Time Frame
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.
Title
The incidence of arrhythmias.
Description
The incidence of arrhythmias, such as atrioventricular block, atrial fibrillation, ventricular tachycardia and so on.
Time Frame
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.
Title
cardiac systolic function:Left Ventricular Ejection Fraction (LVEF)
Description
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.
Time Frame
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.
Title
cardiac diastolic function:E/E' (the ratio of E peak and E') or E/A :(the ratio of E peak and A peak)
Description
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).
Time Frame
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.
Title
tricuspid annular plane systolic excursion(TAPSE)
Description
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).
Time Frame
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.
Title
Respiratory variation in inferior vena cava diameter (DIVC)
Description
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
Time Frame
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.
Title
The number of patients with postoperative hoarseness.
Description
Hoarseness was classified as mild, moderate and severe according to the severity.
Time Frame
Three days after the surgery
Title
The number of patients with postoperative sore throat.
Description
Sore throats can be evaluated using the Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain).
Time Frame
Three days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng Lv, doctor
Organizational Affiliation
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Meng-Lv
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36299870
Citation
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. Erratum In: Front Cardiovasc Med. 2023 Mar 31;10:1190323.
Results Reference
derived

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

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