Effect of Topical Anesthesia Combined With Intravenous Induction on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The area under the curve of baseline blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to accept elective /major cardiac surgery;
- •Patients older than 18 years and younger than 85 years;
- •Patients of The American Society of Anesthesiologists ( ASA )Ⅱ - Ⅳ level grade;
- •Patients signed the informed consent form for the clinical study;
排除标准
- •Patients cannot cooperate to topical anesthesia;
- •Patients with a left cardiac assist device prior to surgery;
- •Patients with aortic dissection;
- •Patients with Intra Aortic Balloon Pump (IABP) prior to surgery;
- •Patients treated with Extracorporeal Membrane Oxygenation (ECMO) prior to surgery;
- •Patients with difficult airway;
- •Patients with high sensitivity and hypersensitivity to lidocaine and tetracaine;
- •Patients with atrioventricular block;
- •Hemoglobin(Hb)<80g/L；
- •Patients who have participated in other clinical studies during the last 3 months;
结局指标
主要结局
The area under the curve of baseline blood pressure
时间窗: 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.
The area under the curve (AUC) of blood pressure below baseline from the beginning of general anesthesia induction to the surgery beginning.
次要结局
- The frequency and types of vasoactive drugs used.(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.)
- The incidence of arrhythmias.(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.)
- cardiac systolic function:Left Ventricular Ejection Fraction (LVEF)(Preoperative, intraoperative)
- cardiac diastolic function:E/E' (the ratio of E peak and E') or E/A :(the ratio of E peak and A peak)(Preoperative, intraoperative)
- cardiac output monitoring indicator: CO(cardiac output)(Intraoperative)
- The number of patients with postoperative sore throat.(Three days after the surgery)
- cardiac output monitoring indicator: SVV(stroke volume variation)(Intraoperative)
- cardiac output monitoring indicator: CI(cardiac index)(Intraoperative)
- cardiac output monitoring indicator: SVR (systemic vascular resistance)(Intraoperative)
- The number of patients with postoperative hoarseness.(Three days after the surgery)
研究者
Lili Cao
Professor
Qianfoshan Hospital