Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421688
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-05
Brief Title:
Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery
Sponsor:
Qianfoshan Hospital
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial a Randomized Double-blind Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None