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Trial · Interventional

CompletedNot applicableRegistry data

Methylene Blue and Postoperative Neurocognitive Disorders

NCTNCT04529265 (opens ClinicalTrials.gov in a new tab)Other id2008222-Exps
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
314 participants (actual)
Sponsor
Fudan University · Other
Design
Randomized · Double masking
Countries
1 country

China

Start
1 May 2021
Primary completion
30 Apr 2023
Completion
30 Dec 2024
First posted
27 Aug 2020
Last update posted
14 May 2025
Conditions
Postoperative Delirium

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022202320242025
  1. N/A

    Methylene Blue and Postoperative Neurocognitive Disorders

    NCT04529265

    1 May 2021 to 30 Dec 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Methylene BlueDrug
  • PlaceboDrug

Arms2

  • Experimental

    Methylene Blue group

    The first dosage: 2mg/kg MB diluted with normal saline into total 50 ml volume intravenous administration after induction of anesthesia within one hour; The second dosage: 1mg/kg MB diluted with normal saline into total 50 ml volume intravenous administration before the end of surgery within 30 minutes.

  • Placebo comparator

    Control group

    The first dosage: normal saline in total 50 ml volume intravenous administration after induction of anesthesia within one hour; The second dosage: normal saline in total 50 ml volume intravenous administration before the end of surgery within 30 minutes.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incidence of postoperative delirium(POD)

    Time frame · Participants will be followed for the duration of hospital stay, an expected average of 7 days.

    Registry description

    the effectiveness of MB in reducing the incidence of POD compared with placebo in patients undergoing pancreatic tumor surgery.

Secondary outcomes(8)

  1. type and duration of POD

    Time frame · Participants will be followed for the duration of hospital stay, an expected average of 7 days

  2. Safety Assessments: incidence of perioperative adverse events

    Time frame · the whole perioperative period

    Registry description

    the incidence of perioperative adverse events to reflect safety of MB administration

  3. neuroinflammation biomarkers

    Time frame · on the day of surgery (before anesthesia and at the end of surgery) and postoperative one day

    Registry description

    the changes in levels of neuroinflammation biomarkers ( IL-6 and IL-8 )between MB group and control group

  4. expressions of inflammatory and adhesion genes in cerebral endothelial cells

    Time frame · before anesthesia and at first day after surgery

    Registry description

    TNF-α, monocyte chemoattractant protein-1 (MCP-1), Claudin 5 (CLND5) and adhesion factors including vascular cell adhesion protein 1 (VCAM-1) and intercellular adhesion molecule 1 (ICAM-1)

  5. numbers of PBMCs adhesion to cerebral endothelial cells

    Time frame · before anesthesia and at first day after surgery

  6. Incidence of postoperative cognitive dysfunction (POCD)

    Time frame · Up to the 7th day after surgery

    Registry description

    the effectiveness of MB in reducing the incidence of POCD compared with placebo in patients undergoing pancreatic tumor surgery.

  7. overall survival

    Time frame · up to 3 years after surgery

    Registry description

    the effectiveness of MB on overall survival compared with placebo in patients undergoing pancreatic tumor surgery.

  8. disease-free survival

    Time frame · up to 3 years after surgery

    Registry description

    the effectiveness of MB on disease-free survival compared with placebo in patients undergoing pancreatic tumor surgery.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2015

5 results

Tau aggregation inhibitor therapy: an exploratory phase 2 study in mild or moderate Alzheimer's disease.

Wischik et al. 2015Journal of Alzheimer's disease : JADcited by 197

PMID 25550228DOI 10.3233/jad-142874PUB-25550228

Full text at the publisher5 results
Publisher pageSee results (5)

More studies

1 study on this page

Indexing hint: Review · 2018

From Mitochondrial Function to Neuroprotection-an Emerging Role for Methylene Blue.

Tucker et al. 2018Molecular neurobiologycited by 117

PMID 28840449PMC5826781DOI 10.1007/s12035-017-0712-2PUB-28840449

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 55 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * preexisted dementia, major depression or other serious mental or neurological disorders * history of allergy to MB or 6-phospho-glucose dehydrogenase deficiency (favism) * MMSE\<24 * illiterate patients * patients diagnosed with rheumatoid diseases such as systemic lupus erythematosus, rheumatoid arthritis and ankylosing spondylitis * 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) * 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) * severe language, visual or auditory deficiency * other neoplastic diseases diagnosed in the past 5 years * participated in other clinical trials within 3 months.

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