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临床试验/NCT05611411
NCT05611411招募中不适用

The Exploration of Maximum Alveolar Concentration of Sevoflurane for Maintaining Effective Spontaneous Respiration

Sixth Affiliated Hospital, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
MaACesr

研究概览

简要总结

Mechanical ventilation will bring many adverse effects. Positive pressure can affect hemodynamics. Inhalation of higher concentrations of oxygen during mechanical ventilation can result in reabsorbed atelectasis for the lungs with a low ventilation-perfusion ratio. Patients who are intubated and mechanically ventilated are at risk for ventilator-associated pneumonia. Mechanical ventilation can induce or aggravate lung injury, called ventilator-induced lung injury (VILI) , Minimizing the duration of mechanical ventilation is the best way to reduce complications.

Sevoflurane is a halogen group of inhaled anesthetics commonly used in clinical, with sedation, analgesia, muscle relaxation. Sevoflurane also inhibited respiratory function, tidal volume decreased with the depth of anesthesia, respiratory rate increased, higher than the conscious respiratory rate, but not enough to fully compensate for the decreased tidal volume. The results showed that with the increase of the depth of anesthesia, the minute ventilation decreased, and the ability to remove carbon dioxide also decreased.

Based on the background of the study and the pharmacological properties of sevoflurane, we sought to explore the maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration in patients, i.e.FiO2 = 30% , PaO2 > 92% , VT > 5 ml/kg, RR > 8/min, PETCO2 < 50 mmHg, sustained > 20s, the time from the beginning of inhalation induction to 1 point OAAS, the changes of hemodynamics during induction, and the recall of induction and operation were also explored.

详细描述

Mechanical ventilation is the most widely used short-term life support technique in the world, which can not only provide good condition for anesthesiologists to manage airway, it can also prevent respiratory muscle fatigue and carbon dioxide accumulation caused by insufficient ventilation.

At the same time, mechanical ventilation will also bring a lot of adverse effects. Positive pressure ventilation can affect hemodynamics, and studies have shown that high intrathoracic pressure, especially high plateau pressure, can adversely affect right ventricular afterload and function. Inhalation of higher concentrations of oxygen during mechanical ventilation can result in reabsorbed atelectasis for the lungs with a low ventilation-perfusion ratio. Patients who are intubated and mechanically ventilated are at risk for ventilator-associated pneumonia due to low oral and pharyngeal secretions, reduced cough efficiency, and impaired mucociliary clearance. Mechanical ventilation can induce or aggravate lung injury, called ventilator-induced lung injury (VILI) .

Minimizing the duration of mechanical ventilation is the best way to reduce complications.

Sevoflurane is a halogen group of inhaled anesthetics commonly used in clinical, with sedation, analgesia, muscle relaxation. The blood/gas distribution coefficient is low and the effect is quick. The elimination mainly depends on the lung exhalation, about 5% passes through the liver metabolism, is affected by the anaesthesia time long little. Long-term low-flow sevoflurane inhalation anesthesia has little effect on liver and kidney function.

Sevoflurane also inhibited respiratory function, tidal volume decreased with the depth of anesthesia, respiratory rate increased, higher than the conscious respiratory rate, but not enough to fully compensate for the decreased tidal volume. The results showed that with the increase of the depth of anesthesia, the minute ventilation decreased, and the ability to remove carbon dioxide also decreased.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-60 years old
  • ASA gradeⅠ~Ⅱ
  • Scheduled for elective surgery under general anesthesia with tracheal intubation

排除标准

  • Elective head and neck and chest surgery patients;
  • Chronic respiratory disease or acute respiratory infection;
  • Indication of difficult airway during preoperative visit;
  • Risk of reflux aspiration;
  • Did not receive regular antihypertensive therapy or blood pressure was not well controlled;
  • Severe organic heart disease;
  • Abnormal function of liver and kidney;
  • Allergic to inhaled anesthetics and known or suspected genetic history of malignant hyperthermia;
  • Mental disorders or long-term history of taking psychotropic drugs and cognitive impairment;
  • History of drug abuse and alcohol abuse;
  • Pregnant or nursing;
  • Participated in any clinical trial as a subject within the last 3 months;
  • Refuse to participate or do not sign or refuse to sign an informed consent form;

结局指标

主要结局

MaACesr

时间窗: 2022.12.01-2023.06.01

maximum alveolar concentration of sevoflurane for maintaining effective spontaneous respiration

次要结局

未报告次要终点

研究者

发起方
Sixth Affiliated Hospital, Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SanQing Jin

Chief anesthesiologist

Sixth Affiliated Hospital, Sun Yat-sen University

研究点 (1)

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