Effect of Perioperative Use of Glycopyrrolate on Lung Function in Elderly Patients Undergoing Laparoscopic Surgery For Gastrointestinal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- the oxygenation index
研究概览
简要总结
Gastrointestinal tumor is one of the highest incidence of malignant tumors in our country, with the incidence increasing year by year. Laparoscopic gastrointestinal surgery ,due to having less bleeding ,small trauma ,Rapid recovery ,has become the main means for the treatment of gastrointestinal surgery. Under general anesthesia, mechanical ventilation can lead to repeated mechanical dilation of alveoli, which can lead to mechanical injury of alveolar epithelium, reduce lung compliance, affect lung function, and increase postoperative complications and hospital stay of patients. Glycopyrrolate acts selectively on M1 and M3 receptors, and is 3-5 times more selective to M3 and M1 receptors than M2 receptors. Therefore, as preoperative medication for elderly patients, it has less effect on the cardiovascular system and can stabilize the heart rate,compared with atropine.However, its influence on the respiratory system in the field of anesthesia is only limited to the study of inhibiting glandular secretion at present, and there are no clear reports on the study of respiratory mechanics. The objective of this study was to evaluate the effect of glycopyrrolate on oxygenation index in elderly patients undergoing radical surgery for gastrointestinal malignant tumor.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 65 yrs or elder;
- •gender unlimited;
- •American Society of Anesthesiologists (ASA) class I to III;
- •an expected surgical duration of at least 2 hrs.
排除标准
- •refusal to participate;
- •known allergy to glycopyrrolate;
- •severe hepatic or renal insufficiency;
- •myasthenia gravis;
- •angle-closure glaucoma;
- •tachycardia detected on the preoperative electrocardiogram (ECG);
- •contraindications to epidural anesthesia;
- •a history of mechanical ventilation within the past six months;
- •severe respiratory disease or restricted thoracic mobility such as thoracic deformity.
研究组 & 干预措施
Control
干预措施: normal saline (Other)
Glycopyrrolate
干预措施: Glycopyrrolate (Drug)
结局指标
主要结局
the oxygenation index
时间窗: at the end of surgery
the oxygenation index(PaO₂ / FiO₂) is calculated and recorded accordingly.
次要结局
- clara cell secretory protein 16 (CC16)(Baseline (prior to the induction of general anesthesia), and at the end of surgery)
- transforming growth factor-β1 (TGF-β1)(Baseline (prior to the induction of general anesthesia), and at the end of surgery)
- the oxygenation index(immediately before the intravenous administration of glycopyrrolate or normal saline, 10 minutes after the establishment of CO2 pneumoperitoneum, and 1 hour after the initiation of CO2 pneumoperitoneum)
- dynamic lung compliance(immediately before the intravenous administration of glycopyrrolate or normal saline, 10 minutes after the establishment of CO₂ pneumoperitoneum, 1 hour after the initiation of CO₂ pneumoperitoneum, and at the end of surgery)
- the alveolar-arterial oxygen gradient(immediately before the intravenous administration of glycopyrrolate or normal saline, 10 minutes after the establishment of CO₂ pneumoperitoneum, 1 hour after the initiation of CO₂ pneumoperitoneum, and at the end of surgery)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University