Ascorbic Acid, Humans, Neurosurgical Procedures, Postoperative Complications, Ventilator-Induced Lung Injury
Conditions
Brief summary
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: 1. To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors. 2. 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. 1. Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia. 2. Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data. 3. 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.
Detailed description
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.
Interventions
DRUGAscorbic acid
After participants underwent induction of anesthesia, Ascorbic acid (Vitamin C Injection) was administered at a dosage of 50 mg/kg, diluted to 50 ml using saline, with a total amount not exceeding 4 g; pumping was performed using a micro pump at a rate of 25 ml/h.
DRUGSaline
After participants underwent induction of anesthesia, 50 ml of saline was used and pumped using a micro pump at a rate of 25 ml/h.
Sponsors
Qianfoshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who need craniotomy treatment due to intracranial tumors; 2. age 18-75 years old; 3. American Society of Anesthesiologists classification: 1\ 3; 4. Patients and their families agree to participate in the study and sign the informed consent form.
Exclusion criteria
1. Patients with severe pulmonary infection or respiratory failure prior to surgery; 2. Patients with previous history of neurological or psychiatric diseases; 3. Patients with cardiac, hepatic and renal insufficiency; 4. patients who are receiving parenteral nutrition; 5. pregnant patients; 6. Patients ruled out by medication instructions; 7. Patients who require emergency surgery; 8. patients with combination of other malignant tumors; 9. patients who have participated in other clinical studies of drugs within 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of postoperative pulmonary complications | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | About 10 days | Length of time between participant's completion of surgery and discharge |
| Oxygenation index | One hour postoperative | PaO2/FiO2, in millimeters of mercury |
| Pain scores | 1 day, 3 days, 7 days postoperative | Patient's postoperative pain level; Using a Pain Visual Analogue Scale, a 10-centimeter-long ruler was used, with 0 indicating no pain and 10 representing the most intense pain that was intolerable. During the test, the participant points to the scale that best represents the level of pain, and the researcher assigns the participant a score based on the location of the point. |
| pulmonary compliance | Last hour of surgery. | lung compliance in Milliliter/ centimeter water column |
| Interleukin-6 | 1 day, 3 days, 7 days postoperative | The level of Interleukin-6 in the blood, in nanograms per liter |
| Neuron-specific enolase levels | Post operative day 1 | Plasma levels of neuron-specific enolase, unit is ng/ml |
| body temperature | 1 day, 3 days, 7 days postoperative | Postoperative body temperature in degrees Celsius |
| blood pressure | About 10 days | Systolic and diastolic blood pressure，In millimeters of mercury |
| Brain-specific cardiolipin | About 3 days | Plasma levels of brain-specific cardiolipin |
| neutrophil | About 10 days | Levels of neutrophils in the blood, measured in units per liter. |
| C-reactive protein | 1 day, 3 days, 7 days postoperative | Level of C-reactive protein in the blood in milligrams per liter |
| superoxide dismutase (SOD) | 1 day, 3 days, 7 days postoperative | Blood levels of superoxide dismutase, in units per milliliter |
Countries
China
Contacts
Primary ContactDong Wang, M.D
Backup ContactLinquan Shao
Outcome results
None listed