NCT04529265Completed
Methylene Blue and Postoperative Neurocognitive Disorders
Effectiveness and Safety of Methylene Blue for Prevention of Postoperative Neurocognitive Disorders in Patients Undergoing Pancreatic Tumor Surgery: A Prospective Randomized Controlled Clinical Trial
Source: ClinicalTrials.gov · Last updated 14 May 2025
Brief summary (registry, in English)
Postoperative Neurocognitive Disorders are the most common neurological complications after major surgery, which are associated with higher increased mortality and morbidity in elderly patients undergoing major surgery. Until now highly effective intervention has not been established yet. Recent preclinical studies suggest neuroinflammation may be linked to pathogensis of (postoperative delirium) POD and postoperative cognitive dysfunction (POCD). As Methylene blue(MB) has neuroprotective and anti-inflammatory properties, and it is a safe drug with long history of clinical use, we propose that inflammation-targeted interventions may be useful to prevent POD/POCD in surgical patients.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 314 (actual)
- First submitted
- 22 Aug 2020
- Start date
- 1 May 2021
- Primary completion date
- 30 Apr 2023
- Lead sponsor
- Fudan University
- Diseases
- Pancreatic cancer
- NCT number
- NCT04529265
What you commit to
- Study type: Interventional
- Participants enrolled: 314
- From 1 May 2021 to the primary completion date, 30 Apr 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- drug or alcohol abuse or recent drug administration that may lead to drug interactions, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs)
Other illness
- preexisted dementia, major depression or other serious mental or neurological disorders
- patients diagnosed with rheumatoid diseases such as systemic lupus erythematosus, rheumatoid arthritis and ankylosing spondylitis
- history of major head trauma
- serious medical diseases (ie. heart failure, pulmonary hypertension, acute stage of myocardial infarction or respiratory failure, hepatic and renal dysfunctions)
- other neoplastic diseases diagnosed in the past 5 years
Lab values
- history of allergy to MB or 6-phospho-glucose dehydrogenase deficiency (favism)
Other
- MMSE\<24
- illiterate patients
- severe language, visual or auditory deficiency
- participated in other clinical trials within 3 months.
Who the study is looking for
- aged 55-80 years old
- planning to undergo pancreatic tumor surgery.
- Patients have the ability to act in full spirit, understand and sign the informed consent, and are willing to complete the whole research process.
Age in the registry: 55 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Cancer Center, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.