Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- incidence of postoperative pulmonary complications
研究概览
简要总结
The goal of this clinical trial is to investigate the effect of perioperative administration of vitamin C on postoperative pulmonary complications, with the aim of providing a safe and effective medication regimen for the prevention and treatment of postoperative pulmonary complications in patients undergoing surgery for craniocerebral tumors. The main questions it aims to answer are:
- To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors.
- Does intraoperative vitamin C improve the prognosis of surgical patients
Researchers will compare vitamin C to a placebo (saline) to see if vitamin C is effective for postoperative lung complications in patients undergoing surgery for cranial tumors.
- Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia.
- Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data.
- Participants will be followed up until discharge from the hospital to record symptoms and adverse events, and will be called at six months to check on their prognosis.
详细描述
Neurosurgery has a high incidence of postoperative pulmonary complications, increasing patient costs and affecting patient prognosis. Neurosurgery often requires hyperventilation to reduce intracranial pressure, so methods to reduce postoperative pulmonary complications such as small tidal volumes cannot be used routinely, and larger tidal volumes often result in injury to pulmonary endothelial cells, which leads to increased permeability of the pulmonary microvasculature, resulting in mechanically ventilated lung injury. Of course surgical injuries and mechanical ventilation can also cause oxidative stress injury to the lungs. Vitamin C is a common antioxidant drug and cofactor in the synthesis of many substances in the body, and many studies have shown that vitamin C prevents the increase in endothelial barrier permeability due to many causes. During the COVID-19 epidemic, vitamin C is seen as an important adjunct in preventing and ameliorating symptoms of COVID-19 patients. not only that, but vitamin C also assisted in postoperative analgesia and promote incision healing, so investigators would like to observe that by giving vitamin C during the surgery is able to prevent the occurrence of postoperative pulmonary complications or improve the prognosis of participants.
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
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need craniotomy treatment due to intracranial tumors;
- •age 18-75 years old;
- •American Society of Anesthesiologists classification: 1~3;
- •Patients and their families agree to participate in the study and sign the informed consent form.
排除标准
- •Patients with severe pulmonary infection or respiratory failure prior to surgery;
- •Patients with previous history of neurological or psychiatric diseases;
- •Patients with cardiac, hepatic and renal insufficiency;
- •patients who are receiving parenteral nutrition;
- •pregnant patients;
- •Patients ruled out by medication instructions;
- •Patients who require emergency surgery;
- •patients with combination of other malignant tumors;
- •patients who have participated in other clinical studies of drugs within 3 months.
研究组 & 干预措施
Ascorbic acid group
Patients received 50 mg/kg of Ascorbic acid after induction of anesthesia
干预措施: Ascorbic acid (Drug)
Control comparator group
Patients receive 50ml saline after induction of anesthesia
干预措施: Saline (Drug)
结局指标
主要结局
incidence of postoperative pulmonary complications
时间窗: About 10 days
This will be assessed using the Postoperative Pulmonary Complications Score, which ranges from 0 to 5, with a score of ≥3 being considered positive for postoperative pulmonary complications. It was assessed every day before discharge and the highest score that occurred was recorded.
次要结局
- Oxygenation index(One hour postoperative)
- pulmonary compliance(Last hour of surgery.)
- Interleukin-6(1 day, 3 days, 7 days postoperative)
- superoxide dismutase (SOD)(1 day, 3 days, 7 days postoperative)
- body temperature(1 day, 3 days, 7 days postoperative)
- Pain scores(1 day, 3 days, 7 days postoperative)
- Neuron-specific enolase levels(Post operative day 1)
- Length of hospitalization(About 10 days)
- blood pressure(About 10 days)
- Brain-specific cardiolipin(About 3 days)
- neutrophil(About 10 days)
- C-reactive protein(1 day, 3 days, 7 days postoperative)
研究者
Dong Wang
Principal Investigator
Qianfoshan Hospital
