NCT06421688

Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery

Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Qianfoshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ascorbic Acid
• Neurosurgical Procedures
• Humans
• Ventilator-Induced Lung Injury
• Postoperative Complications

Interventions

Type	Name	Description
DRUG	Ascorbic 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.
DRUG	Saline	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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-01-01
• Completion: 2025-06-01
• First posted: 2024-05-20
• Last updated: 2024-05-20

Locations

1 site across 1 country: China