Clinical trial NCT06421688: Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery
Official title: Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial: a Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Ascorbic Acid
Neurosurgical Procedures
Humans
Ventilator-Induced Lung Injury
Postoperative Complications
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: incidence of postoperative pulmonary complications
timeFrame: About 10 days
Secondary outcomes:
measure: Neuron-specific enolase levels
timeFrame: Post operative day 1
measure: Length of hospitalization
timeFrame: About 10 days
measure: Oxygenation index
timeFrame: One hour postoperative
measure: Pain scores
timeFrame: 1 day, 3 days, 7 days postoperative
measure: pulmonary compliance
timeFrame: Last hour of surgery.
measure: Interleukin-6
timeFrame: 1 day, 3 days, 7 days postoperative
measure: superoxide dismutase (SOD)
timeFrame: 1 day, 3 days, 7 days postoperative
measure: body temperature
timeFrame: 1 day, 3 days, 7 days postoperative
measure: blood pressure
timeFrame: About 10 days
measure: Brain-specific cardiolipin
timeFrame: About 3 days
measure: neutrophil
timeFrame: About 10 days
measure: C-reactive protein
timeFrame: 1 day, 3 days, 7 days postoperative
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Dong Wang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sogame LC, Vidotto MC, Jardim JR, Faresin SM. Incidence and risk factors for postoperative pulmonary complications in elective intracranial surgery. J Neurosurg. 2008 Aug;109(2):222-7. doi: 10.3171/JNS/2008/109/8/0222.
citation: May JM, Harrison FE. Role of vitamin C in the function of the vascular endothelium. Antioxid Redox Signal. 2013 Dec 10;19(17):2068-83. doi: 10.1089/ars.2013.5205. Epub 2013 May 29.
citation: Holford P, Carr AC, Jovic TH, Ali SR, Whitaker IS, Marik PE, Smith AD. Vitamin C-An Adjunctive Therapy for Respiratory Infection, Sepsis and COVID-19. Nutrients. 2020 Dec 7;12(12):3760. doi: 10.3390/nu12123760.
citation: Wang D, Wang M, Zhang H, Zhu H, Zhang N, Liu J. Effect of Intravenous Injection of Vitamin C on Postoperative Pulmonary Complications in Patients Undergoing Cardiac Surgery: A Double-Blind, Randomized Trial. Drug Des Devel Ther. 2020 Aug 11;14:3263-3270. doi: 10.2147/DDDT.S254150. eCollection 2020.
citation: Costa Leme A, Hajjar LA, Volpe MS, Fukushima JT, De Santis Santiago RR, Osawa EA, Pinheiro de Almeida J, Gerent AM, Franco RA, Zanetti Feltrim MI, Nozawa E, de Moraes Coimbra VR, de Moraes Ianotti R, Hashizume CS, Kalil Filho R, Auler JO Jr, Jatene FB, Gomes Galas FR, Amato MB. Effect of Intensive vs Moderate Alveolar Recruitment Strategies Added to Lung-Protective Ventilation on Postoperative Pulmonary Complications: A Randomized Clinical Trial. JAMA. 2017 Apr 11;317(14):1422-1432. doi: 10.1001/jama.2017.2297.