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

NCT04744480 | Completed

• 1 other identifier: TACTICS
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Valvular Heart Disease; Arrhythmia; Myocardial Disease

Keywords

Topical anesthesia; Cardiac surgery; Hemodynamics; Induction period

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• The frequency and types of vasoactive drugs used.

  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.

  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)

  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)

  Preoperative, intraoperative

• cardiac output monitoring indicator: CO(cardiac output)

  Intraoperative

Study Arms (2)

The combined topical anesthesia induction group

EXPERIMENTAL

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 routine induction group

NO INTERVENTION

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.

Interventions

The combined topical anesthesia induction group PROCEDURE

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 combined topical anesthesia induction group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Meng-Lv

Jinan, Shandong, 250000, China

Location

Related Publications (1)

• 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.

  PMID: 35078841 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Arrhythmias, Cardiac; Cardiomyopathies

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Meng Lv, doctor

  Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: February 9, 2021
• Study Start: March 5, 2021
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2022
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)