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

NCT05323786 | Completed

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

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.

Conditions

Coronary Artery Disease; Valvular Heart Disease; Arrythmia

Keywords

Topical anesthesia; Atomization inhalation; Cardiac surgery; Hemodynamics; Endotracheal intubation

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 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 Outcomes (11)

• The area under the curve of baseline blood pressure

  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

  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.

  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.

  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.

  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.

Study Arms (2)

The combined topical anesthesia induction group

EXPERIMENTAL

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

The routine induction group

PLACEBO COMPARATOR

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

Interventions

The combined topical anesthesia induction group PROCEDURE

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.

The combined topical anesthesia induction group

The routine induction group PROCEDURE

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.

The routine induction group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

Meng-Lv

Jinan, Shandong, 250000, China

Location

Related Publications (1)

• 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.

  PMID: 36299870 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Arrhythmias, Cardiac

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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 12, 2022
• Study Start: April 20, 2022
• Primary Completion: January 19, 2023
• Study Completion: January 21, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)