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

NCT ID: NCT04744480

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2022-04-27

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.

Conditions

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

Study Design

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

Study Groups

The combined topical anesthesia induction group

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.

Group Type: EXPERIMENTAL

The combined topical anesthesia induction group

Intervention Type: 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 routine induction group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The combined topical anesthesia induction group

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 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

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.

Reference Type: DERIVED

PMID: 35078841 (View on PubMed)

Other Identifiers

TACTICS

Identifier Type: -

Identifier Source: org_study_id