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

Q

Qianfoshan Hospital

Status

Completed

Conditions

Coronary Artery Disease
Arrythmia
Valvular Heart Disease

Treatments

Procedure: The routine induction group
Procedure: The combined topical anesthesia induction group

Study type

Interventional

Funder types

Other

Identifiers

NCT05323786
TACTICS-Ⅱ

Details and patient eligibility

About

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.

Full 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.

Enrollment

96 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

96 participants in 2 patient groups, including a placebo group

The combined topical anesthesia induction group
Experimental group
Description:
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.
Treatment:
Procedure: The combined topical anesthesia induction group
The routine induction group
Placebo Comparator group
Description:
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.
Treatment:
Procedure: The routine induction group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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