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

Primary Purpose

Coronary Artery Disease, Valvular Heart Disease, Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The combined topical anesthesia 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, Cardiac surgery, Hemodynamics, Induction period

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Meng-Lv

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The combined topical anesthesia induction group

The routine induction group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The frequency and types of vasoactive drugs used.
The frequency and types 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 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)
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)
CO＝Stroke Output (SV)× Heart Rate (HR).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
cardiac output monitoring indicator: SVV(stroke volume variation)
The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
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.
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.
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.

Full Information

First Posted
January 24, 2021
Last Updated
May 28, 2022
Sponsor
Qianfoshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04744480
Brief Title
Effect of Topical Anesthesia on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery.
Official Title
Effect of Topical Anesthesia Combined With Intravenous Induction on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
April 27, 2022 (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
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.

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, Arrhythmia, Myocardial Disease
Keywords
Topical anesthesia, Cardiac surgery, Hemodynamics, Induction period

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
The combined topical anesthesia induction group
Arm Type
Experimental
Arm Description
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.
Arm Title
The routine induction group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
The combined topical anesthesia induction group
Intervention Description
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 Measure Information:
Title
The area under the curve of baseline blood pressure
Description
The area under the curve (AUC) of blood pressure below baseline from the beginning of general anesthesia induction to the surgery beginning.
Time Frame
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 Measure Information:
Title
The frequency and types of vasoactive drugs used.
Description
The frequency and types of vasoactive drugs used ,such as the use of norepinephrine and dopamine.
Time Frame
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.
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 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.
Title
cardiac systolic function:Left Ventricular Ejection Fraction (LVEF)
Description
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﹪
Time Frame
Preoperative, intraoperative
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 indicators for evaluating diastolic function, indicated normal diastolic function when E/A >1, and decreased diastolic function when E/A < 1.
Time Frame
Preoperative, intraoperative
Title
cardiac output monitoring indicator: CO(cardiac output)
Description
CO＝Stroke Output (SV)× Heart Rate (HR).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
Time Frame
Intraoperative
Title
cardiac output monitoring indicator: SVV(stroke volume variation)
Description
The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
Time Frame
Intraoperative
Title
cardiac output monitoring indicator: CI(cardiac index)
Description
CI＝CO/ Body Surface Area (BSA).The relevant parameters are obtained by the cardiac output monitor which produced by Edwards Lifesciences.
Time Frame
Intraoperative
Title
cardiac output monitoring indicator: SVR (systemic vascular resistance)
Description
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.
Time Frame
Intraoperative
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.
Time Frame
Three days after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled to accept elective /major cardiac surgery; Patients older than 18 years and younger than 85 years; Patients of The American Society of Anesthesiologists ( ASA )Ⅱ - Ⅳ level grade; Patients signed the informed consent form for the clinical study; Exclusion Criteria: Patients cannot cooperate to topical anesthesia; Patients with a left cardiac assist device prior to surgery; Patients with aortic dissection; Patients with Intra Aortic Balloon Pump (IABP) prior to surgery; Patients treated with Extracorporeal Membrane Oxygenation (ECMO) prior to surgery; Patients with difficult airway; Patients with high sensitivity and hypersensitivity to lidocaine and tetracaine; Patients with atrioventricular block; Hemoglobin(Hb)<80g/L； 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
35078841
Citation
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.
Results Reference
derived

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

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