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Trial Title:
Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery
NCT ID:
NCT06421688
Condition:
Ascorbic Acid
Neurosurgical Procedures
Humans
Ventilator-Induced Lung Injury
Postoperative Complications
Conditions: Official terms:
Lung Injury
Ventilator-Induced Lung Injury
Postoperative Complications
Ascorbic Acid
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Ascorbic acid
Description:
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.
Arm group label:
Ascorbic acid group
Other name:
vitamin C
Intervention type:
Drug
Intervention name:
Saline
Description:
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.
Arm group label:
Control comparator group
Other name:
saline (medicine)
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Shandong First Medical University
Address:
City:
Jinan
Zip:
250000
Country:
China
Contact:
Last name:
Dong Wang, Doctor of Medicine(M.D.)
Phone:
+86-18353173516
Email:
ngbaise@163.com
Start date:
June 1, 2024
Completion date:
June 2025
Lead sponsor:
Agency:
Qianfoshan Hospital
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06421688
