Effect of Vitamin C on Postoperative Pulmonary Complications After Intracranial Tumor Surgery

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421688
• Other study ID #: YXLL-KY-2024(039)
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Qianfoshan Hospital
• Contact: Dong Wang, M.D
• Phone: 18353173516
• Email: ngbaise[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ascorbic Acid
• Humans
• Lung Injury
• Postoperative Complications
• Ventilator-Induced Lung Injury

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Neuron-specific enolase levels	Plasma levels of neuron-specific enolase, unit is ng/ml	Post operative day 1
Secondary	Length of hospitalization	Length of time between participant's completion of surgery and discharge	About 10 days
Secondary	Oxygenation index	PaO2/FiO2, in millimeters of mercury	One hour postoperative
Secondary	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
Secondary	pulmonary compliance	lung compliance in Milliliter/ centimeter water column	Last hour of surgery.
Secondary	Interleukin-6	The level of Interleukin-6 in the blood, in nanograms per liter	1 day, 3 days, 7 days postoperative
Secondary	superoxide dismutase (SOD)	Blood levels of superoxide dismutase, in units per milliliter	1 day, 3 days, 7 days postoperative
Secondary	body temperature	Postoperative body temperature in degrees Celsius	1 day, 3 days, 7 days postoperative
Secondary	blood pressure	Systolic and diastolic blood pressure,In millimeters of mercury	About 10 days
Secondary	Brain-specific cardiolipin	Plasma levels of brain-specific cardiolipin	About 3 days
Secondary	neutrophil	Levels of neutrophils in the blood, measured in units per liter.	About 10 days
Secondary	C-reactive protein	Level of C-reactive protein in the blood in milligrams per liter	1 day, 3 days, 7 days postoperative