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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ascorbic acid group | Experimental | Patients received 50 mg/kg of Ascorbic acid after induction of anesthesia |
|
| Control comparator group | Placebo Comparator | Patients receive 50ml saline after induction of anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic acid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of postoperative pulmonary complications | This will be assessed using the Postoperative Pulmonary Complications Score, which ranges from 0 to 5, with a score of ≥3 being considered positive for postoperative pulmonary complications. It was assessed every day before discharge and the highest score that occurred was recorded. | About 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Neuron-specific enolase levels | Plasma levels of neuron-specific enolase, unit is ng/ml | Post operative day 1 |
| Length of hospitalization | Length of time between participant's completion of surgery and discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Wang, M.D | Contact | 18353173516 | ngbaise@163.com | |
| Linquan Shao | Contact | 15864548531 | 2210068491@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dong Wang, M.D | Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Jinan | Shandong | 250000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18671633 | Background | 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. | |
| 23581713 | Background | 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. |
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Individual Participant Data(IPD) will be available when this trial is finished and the article have been published
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| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D012965 | Sodium Chloride |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
|
| Saline | Drug | 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. |
|
|
| About 10 days |
| Oxygenation index | PaO2/FiO2, in millimeters of mercury | One hour postoperative |
| Pain scores | Patient's postoperative pain level; Using a "Pain Visual Analogue Scale", a 10-centimeter-long ruler was used, with 0 indicating no pain and 10 representing the most intense pain that was intolerable. During the test, the participant points to the scale that best represents the level of pain, and the researcher assigns the participant a score based on the location of the point. | 1 day, 3 days, 7 days postoperative |
| pulmonary compliance | lung compliance in Milliliter/ centimeter water column | Last hour of surgery. |
| Interleukin-6 | The level of Interleukin-6 in the blood, in nanograms per liter | 1 day, 3 days, 7 days postoperative |
| superoxide dismutase (SOD) | Blood levels of superoxide dismutase, in units per milliliter | 1 day, 3 days, 7 days postoperative |
| body temperature | Postoperative body temperature in degrees Celsius | 1 day, 3 days, 7 days postoperative |
| blood pressure | Systolic and diastolic blood pressure,In millimeters of mercury | About 10 days |
| Brain-specific cardiolipin | Plasma levels of brain-specific cardiolipin | About 3 days |
| neutrophil | Levels of neutrophils in the blood, measured in units per liter. | About 10 days |
| C-reactive protein | Level of C-reactive protein in the blood in milligrams per liter | 1 day, 3 days, 7 days postoperative |
| 33297491 | Background | 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. |
| 32848365 | Background | 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. |
| 28322416 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |