Methylene Blue and Postoperative Neurocognitive Disorders

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Methylene Blue group (experimental) and Control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The studies have indicated that MB, as a redox mediator in the electron transfer chain (ETC), restores mitochondrial function and enhances brain metabolism.

Who Took Part

314 actual participants took part.

It was open to people of any sex aged from 55 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: preexisted dementia, major depression or other serious mental or neurological disorders; history of allergy to mb or 6-phospho-glucose dehydrogenase deficiency (favism); illiterate patients.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2021-05-01 with completion listed for 2023-04-30.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Incidence of postoperative delirium(POD) (time frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days).

It also tracked 8 secondary outcomes, for example type and duration of POD, Safety Assessments: incidence of perioperative adverse events, neuroinflammation biomarkers, expressions of inflammatory and adhesion genes in cerebral endothelial cells, numbers of PBMCs adhesion to cerebral endothelial cells and Incidence of postoperative cognitive dysfunction (POCD).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 314 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.