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

NCT06421688 | Not Yet Recruiting Phase 2

• 1 other identifier: YXLL-KY-2024(039)
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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. 1.To determine whether vitamin C can reduce pulmonary complications after surgery for intracranial tumors.
2. 2.Does intraoperative vitamin C improve the prognosis of surgical patients
3. 3.Participants will be intravenously pumped with vitamin C for two hours after induction of anesthesia.
4. 4.Participants will have intraoperative plasma sampling and recording of ventilator parameters, monitor parameters and perioperative data.
5. 5.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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Neuron-specific enolase levels

  Post operative day 1

• Length of hospitalization

  About 10 days

• Oxygenation index

  One hour postoperative

• Pain scores

  1 day, 3 days, 7 days postoperative

• pulmonary compliance

  Last hour of surgery.

Study Arms (2)

Ascorbic acid group

EXPERIMENTAL

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

Drug: Ascorbic acid

Control comparator group

PLACEBO COMPARATOR

Patients receive 50ml saline after induction of anesthesia

Drug: Saline

Interventions

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.

Also known as: vitamin C

Ascorbic acid group

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.

Also known as: saline (medicine)

Control comparator group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who need craniotomy treatment due to intracranial tumors;
• age 18-75 years old;
• American Society of Anesthesiologists classification: 1\~3;
• Patients and their families agree to participate in the study and sign the informed consent form.

You may not qualify if:

• Patients with severe pulmonary infection or respiratory failure prior to surgery;
• Patients with previous history of neurological or psychiatric diseases;
• Patients with cardiac, hepatic and renal insufficiency;
• patients who are receiving parenteral nutrition;
• pregnant patients;
• Patients ruled out by medication instructions;
• Patients who require emergency surgery;
• patients with combination of other malignant tumors;
• patients who have participated in other clinical studies of drugs within 3 months.

Sponsors & Collaborators

• Qianfoshan Hospital: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250000, China

Location

Related Publications (5)

• 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.

  PMID: 18671633 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.

  PMID: 23581713 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.

  PMID: 33297491 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.

  PMID: 32848365 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.

  PMID: 28322416 BACKGROUND

MeSH Terms

Conditions

Ventilator-Induced Lung Injury; Postoperative Complications

Interventions

Ascorbic Acid; Sodium Chloride; Dosage Forms

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Dong Wang, M.D

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wang, M.D

CONTACT

18353173516; ngbaise@163.com

Linquan Shao

CONTACT

15864548531; 2210068491@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2024
• First Posted: May 20, 2024
• Study Start: June 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

CN (1)