局部气道麻醉对心脏手术患者诱导期血流动力学的影响：一项随机对照试验的研究方案。

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.

作者信息

Du Wenya, Lv Meng, Chen Tingting, Sun Xiaxuan, Wang Jihua, Zhang Haixia, Wei Chuansong, Liu Yi, Qiao Changlong, Wang Yuelan

机构信息

Department of Anesthesiology, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Shandong Institute of Anesthesia and Respiratory Critical Care Medicine, Jinan, China.

Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan, China.

出版信息

Front Cardiovasc Med. 2022 Oct 10;9:992534. doi: 10.3389/fcvm.2022.992534. eCollection 2022.

DOI:10.3389/fcvm.2022.992534

PMID:36299870

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9589145/

Abstract

BACKGROUND

Patients scheduled for cardiac surgery are often accompanied by cardiac dysfunction and hemodynamic instability. However, the conventional induction strategy for anesthesia using high-dose intravenous anesthetics is often associated with persistent and recurrent hypotension after tracheal intubation. The purpose of this study is to investigate the effects of topical airway anesthesia on the hemodynamic profile of patients undergoing cardiac surgery during the induction period.

METHODS

This is a superiority, single-blind, randomized controlled study with two parallel groups. Participants scheduled to undergo elective cardiac surgery will be allocated into two blocks according to the New York Heart Association (NYHA) classification and then randomly assigned to the following two groups at a 1:1 ratio: the conventional induction group and the combined topical airway anesthesia induction group. The combined topical airway anesthesia induction strategy includes aerosol inhalation airway anesthesia, subglottic airway anesthesia, and general anesthesia induction using low-dose intravenous anesthetics. The primary outcome is the area under the curve (AUC) of blood pressure below baseline mean arterial pressure (MAP) from 3 to 15 min after endotracheal intubation. Secondary outcomes include the AUC above baseline MAP and below baseline MAP at other time points, the highest and lowest arterial blood pressure values during the induction period, type and dose of vasoactive drugs, incidence of arrhythmias, cardiac function, and the incidence of postoperative hoarseness and sore throat.

DISCUSSION

The study will explore whether aerosol inhalation airway anesthesia and subglottic airway anesthesia could reduce the incidence and duration of hypotension during the induction period in patients undergoing cardiac surgery.

CLINICAL TRIAL REGISTRATION

This trial was registered on www.ClinicalTrials.gov (NCT05323786).

摘要

背景

计划进行心脏手术的患者常伴有心脏功能障碍和血流动力学不稳定。然而，使用高剂量静脉麻醉药的传统麻醉诱导策略通常与气管插管后持续和反复的低血压有关。本研究的目的是探讨局部气道麻醉对心脏手术患者诱导期血流动力学的影响。

方法

这是一项具有两个平行组的优效性、单盲、随机对照研究。计划接受择期心脏手术的参与者将根据纽约心脏协会（NYHA）分级分为两个区组，然后以1:1的比例随机分配到以下两组：传统诱导组和联合局部气道麻醉诱导组。联合局部气道麻醉诱导策略包括雾化吸入气道麻醉、声门下气道麻醉以及使用低剂量静脉麻醉药进行全身麻醉诱导。主要结局是气管插管后3至15分钟血压低于基线平均动脉压（MAP）的曲线下面积（AUC）。次要结局包括其他时间点高于基线MAP和低于基线MAP的AUC、诱导期最高和最低动脉血压值、血管活性药物的类型和剂量、心律失常的发生率、心脏功能以及术后声音嘶哑和咽痛的发生率。