Clinical trial NCT05323786: Hemodynamic Effect of Topical Anesthesia During Induction in Patients Undergoing Cardiac Surgery
Official title: Effect of Topical Anesthesia on Hemodynamics During Induction in Patients Undergoing Cardiac Surgery: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Valvular Heart Disease
Arrythmia
Keywords: Topical anesthesia
Atomization inhalation
Cardiac surgery
Hemodynamics
Endotracheal intubation
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The area under the curve of baseline blood pressure
timeFrame: 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:
measure: The area under the curve of baseline blood pressure
timeFrame: 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.
measure: The highest and lowest values of arterial blood pressure
timeFrame: 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.
measure: The types of vasoactive drugs used.
timeFrame: 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.
measure: The frequency of vasoactive drugs used.
timeFrame: 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.
measure: The incidence of arrhythmias.
timeFrame: 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.
measure: cardiac systolic function:Left Ventricular Ejection Fraction (LVEF)
timeFrame: Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours.
measure: cardiac diastolic function:E/E' (the ratio of E peak and E') or E/A :(the ratio of E peak and A peak)
timeFrame: Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours.
measure: tricuspid annular plane systolic excursion(TAPSE)
timeFrame: Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours.
measure: Respiratory variation in inferior vena cava diameter (DIVC)
timeFrame: Beginning of the general anaesthesia induction(T1) is when midazolam is administered. T2 is when central venous catheterization is finished. It will take up to 1hour or 2hours.
measure: The number of patients with postoperative hoarseness.
timeFrame: Three days after the surgery
measure: The number of patients with postoperative sore throat.
timeFrame: Three days after the surgery
Other outcomes:
Locations:
city: Jinan
country: China
facility: Meng-Lv
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
name: Meng Lv, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.