Effect of Methylene Blue on Perioperative Organ Function in Patients With Obstructive Jaundice

What Was Tested

In this phase 1 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Methylene blue group (experimental) and Placebo group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

As a direct opener of KATP channels in vivo, H2S also has diastolic peripheral vasculature .

H2S participates in the occurrence of vasoplegic syndrome in patients with obstructive jaundice by interacting with NO.

However, it is unclear whether methylene blue can relieve vasoplegic syndrome in patients with obstructive jaundice by inhibiting the vasodilating effect of substances such as H2S and NO.

Therefore, this clinical study intends to include patients with obstructive jaundice, using randomized, controlled, prospective study to explore the effect of methylene blue on the occurrence of vasoplegic syndrome, organ function and prognosis in patients with obstructive jaundice.

Who Took Part

64 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age: 18\~70 years old;. ASA grade I\~III;. Ability to comply with research protocols;. Patients with obstructive jaundice: patients with total bilirubin greater than 50umol/L;. Voluntarily participate in the study and sign the informed consent form. -.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: ASA IV\~V grade;; women during lactation and pregnancy;; patients with severe heart disease or lung disease before surgery;.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

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

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-04-01 with completion listed for 2021-01-21.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Acute physiology and chronic health evaluation IIScore sheet (time frame: 3 days).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Methylene blue (non-peptide stack partner) in 64 people.

Its status is unknown; 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.