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

NCT ID: NCT05323786

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2023-01-21

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.

Conditions

Coronary Artery Disease; Valvular Heart Disease; Arrythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

The combined topical anesthesia induction group

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.

Group Type: EXPERIMENTAL

The combined topical anesthesia induction group

Intervention Type: 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 routine induction group

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.

Group Type: PLACEBO_COMPARATOR

The routine induction group

Intervention Type: 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.

Interventions

The combined topical anesthesia induction group

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

The routine induction group

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

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lili Cao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Meng Lv, doctor

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Meng-Lv

Jinan, Shandong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36299870 (View on PubMed)

Other Identifiers

TACTICS-Ⅱ

Identifier Type: -

Identifier Source: org_study_id