Clinical trial

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

Name

YXLL-KY-2024(039)

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2025-01-01

Trial end

2025-06-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

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.

Arms:

Ascorbic acid group

Other names:

vitamin C

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.

Arms:

Control comparator group

Other names:

saline (medicine)

Size

Primary endpoint

incidence of postoperative pulmonary complications

About 10 days

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 86, 'type': 'ESTIMATED'}}

Updated at

2024-05-20

1 organization

1 product

1 drug

5 indications

Organization

Qianfoshan Hospital

Product

Ascorbic acid

Indication

Vitamin C