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

NCT ID: NCT06421688

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2025-06-30

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.

Conditions

Ascorbic Acid; Neurosurgical Procedures; Humans; Ventilator-Induced Lung Injury; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Ascorbic acid group

Patients received 50 mg/kg of Ascorbic acid after induction of anesthesia

Group Type: EXPERIMENTAL

Ascorbic acid

Intervention Type: 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.

Control comparator group

Patients receive 50ml saline after induction of anesthesia

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

vitamin C; saline (medicine)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qianfoshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dong Wang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Wang, M.D

Role: PRINCIPAL_INVESTIGATOR

Shandong First Medical University

Locations

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Countries

China

Central Contacts

Dong Wang, M.D

Role: CONTACT

ngbaise@163.com

18353173516

Linquan Shao

Role: CONTACT

2210068491@qq.com

15864548531

Facility Contacts

Dong Wang, Doctor of Medicine(M.D.)

Role: primary

ngbaise@163.com

+86-18353173516

References

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.

Reference Type: BACKGROUND

PMID: 18671633 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23581713 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33297491 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32848365 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28322416 (View on PubMed)

Other Identifiers

YXLL-KY-2024(039)

Identifier Type: -

Identifier Source: org_study_id