Clinical trial NCT04744480: Effect of Topical Anesthesia on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery.
Official title: Effect of Topical Anesthesia Combined With Intravenous Induction on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Valvular Heart Disease
Arrhythmia
Myocardial Disease
Keywords: Topical anesthesia
Cardiac surgery
Hemodynamics
Induction period
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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;

Primary outcomes:
measure: The area under the curve of baseline blood pressure
timeFrame: From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.
Secondary outcomes:
measure: The frequency and types of vasoactive drugs used.
timeFrame: From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.
measure: The incidence of arrhythmias.
timeFrame: From the beginning of general anesthesia induction(T1) to the surgery beginning(T2). T1 is when induction drug (midazolam) is administered. T2 is defined as the time of the skin incision. It will take up to 1hour or 2hours.
measure: cardiac systolic function:Left Ventricular Ejection Fraction (LVEF)
timeFrame: Preoperative, intraoperative
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: Preoperative, intraoperative
measure: cardiac output monitoring indicator: CO(cardiac output)
timeFrame: Intraoperative
measure: cardiac output monitoring indicator: SVV(stroke volume variation)
timeFrame: Intraoperative
measure: cardiac output monitoring indicator: CI(cardiac index)
timeFrame: Intraoperative
measure: cardiac output monitoring indicator: SVR (systemic vascular resistance)
timeFrame: Intraoperative
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: 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.