Intraoperative Infusion of Methylene Blue for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery

What Was Tested

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

Postoperative neurocognitive impairments often occur in elderly patients undergoing anesthesia and non-cardiac surgery, including postoperative delirium (POD) and postoperative cognitive dysfunction (POCD).

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

The registry classes the interventions as drug.

More on the Plan

Methylene blue(MB) is a diaminophenothiazine with a long history of clinical use due to its minimal side effect profiles.

MB currently is used for treatment of methemoglobinemia, carbon monoxide poisoning, and vasoplegic syndrome as well as for surgical staining.

MB could diffuse rapidly into brain and accumulate in the cytoplasm and mitochondria of neurons.

Who Took Part

The registry lists 248 actual participants took part.

It was open to people of any sex aged from 60 years up to 80 years.

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

Examples of who could join: Aged 60-80 years old. Planning to undergo non-cardiac and non-neurosurgical surgery (e.g..thoracic, orthopaedic, urologic and major abdominal surgeries) under general anesthesia. Liver and kidney function are normal. 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 5 inclusion and 11 exclusion criteria; among the exclusions: patients with personal history of allergy to methylene blue; emergency surgery; patients have 6-phospho-glucose dehydrogenase deficiency (vicia faba disease).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

It started in 2019-01-14 with completion listed for 2020-04-30.

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 5 days).

It also tracked 3 secondary outcomes, for example Incidence of postoperative cognitive dysfunction (POCD), Safety Assessments: incidence of perioperative adverse events and Oxidative Stress Biomarkers.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 248 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.