Effect of Sevoflurane and Remimazolam on Arterial Oxygenation During One-lung Ventilation: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- PaO2 after 30 minutes of OLV (T2)
研究概览
简要总结
The goal of this clinical trial is to compare the effect of sevoflurane and remimazolam on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.
详细描述
One lung ventilation (OLV) is a mechanical ventilation method used during thoracic surgery to collapse the non-ventilated lung and secure the surgical field. During one lung ventilation, the pulmonary artery of the collapsed lung undergoes vasoconstriction in response to hypoxia, which increases the blood flow of the normally ventilated lung as a compensatory physiological response. This is known as hypoxic pulmonary vasoconstriction (HPV). Therefore, by using HPV, arterial blood oxygenation can be maintained and pulmonary shunting can be reduced, preventing hypoxemia during one lung ventilation.
The two most commonly used anesthetics in thoracic surgery are sevoflurane, an inhaled anesthetic, and propofol, an intravenous anesthetic. Previous studies have shown that there were no significant differences between two anesthetics on arterial oxygenation during one lung ventilation because sevoflurane administered in clinical concentrations of 1 minimum alveolar concentration (MAC) resulted in similar changes in shunt fraction as did propofol.
However, the effect of remimazolam on arterial blood oxygenation and intrapulmonary shunt during one lung ventilation has not been revealed. Therefore, this study is designed to compare the effect of remimazolam and sevoflurane anesthesia on arterial oxygenation during one lung ventilation in patients undergoing video-assisted thoracoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing video-assisted thoracoscopic surgery
- •19 years of age or older, less than 80 years old
- •The American Society of Anesthesiologists (ASA) classification I-Ⅲ physical status
排除标准
- •Patients with known allergy to benzodiazepine, propofol
- •Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Patients with hypersensitivity to Dextran40
- •Patients with end stage renal disease requiring hemodialysis
- •Patients with history of acute angle glaucoma
- •Emergency operation
- •Patients with unstable hemodynamics requiring inotropics
- •Patients with preoperative oxygen supplement
- •Preoperative forced expiratory volume (FEV1) less than 40% of predicted
- •Preoperative ejection fraction less than 50%
研究组 & 干预措施
Remimazolam group
To induce anesthesia, remimazolam is continuously infused in a dose of 6mg/kg/hr with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). Maintenance dose of remimazolam is 1mg/kg/hr, up to 2mg/kg/hr, and remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia.
干预措施: Remimazolam (Drug)
Sevoflurane group
To induce anesthesia, 1% propofol 1.5-2.5mg/kg is used with remifentanil (Ce of 1-4ng/ml) by target-controlled infusion (TCI). After patient loses consciousness, anesthesia is maintained through the inhalation of sevoflurane between 1-2 minimum alveolar concentrations (MAC). Remifentanil is titrated to maintain the bispectral index (BIS) between 40 and 60 to achieve appropriate anesthetic depth during general anesthesia.
干预措施: 1% propofol (Drug)
结局指标
主要结局
PaO2 after 30 minutes of OLV (T2)
时间窗: arterial blood sampling will be taken over four times: T0 (after 10 minute of TLV in lateral decubitus position), T1 (after 15 minutes of OLV), T2 (after 30 minutes of OLV), T3 (after 60 minutes of OLV)
compare the arterial oxygenation after 30 minutes of one lung ventilation between two groups
次要结局
- Changes of PaCO2(During 60 minutes of OLV)
- Changes of ORI(During 60 minutes of OLV)
- Changes of PaO2(During 60 minutes of OLV)
- Changes of P/F ratio(During 60 minutes of OLV)
- The lowest PaO2(During 60 minutes of OLV)
- Changes of MAP(During 60 minutes of OLV)
研究者
Kim Hee Young
Assistant professor for fund
Pusan National University Yangsan Hospital