Pre-treatment With Methylene Blue Prevent Peri-operative Reduced Systemic Vascular Resistance

Plain-language guide to NCT03406676: not phased randomized trial of Methylene blue (non-peptide stack partner), 70 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03406676
Phase: not phased
Status: status unknown
Start: 2017-08-01
Completion (planned or actual): 2018-10-30
Participants: 70 (estimated)
Design: randomized, double-blind, prevention
Conditions studied: Obstructive Jaundice
Results posted: not yet

What This Study Did, in Plain Language

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 (experimental) and saline (no intervention).

The registry classes the interventions as drug.

More on the Plan

Hemodynamic characteristics of patients with obstructive jaundice are high cardiac output, low peripheral vascular resistance.

Who Took Part

70 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: Aged between 18-60 years;. American Society of Anesthesiologists（ASA） grade I\~III;. TBIL\>ULN and TBA\>ULN; The patients with obstructive jaundice.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: organs dysfunction(heart,lungs and etc);; mental disorders;; in other clinical trial.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

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

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 and outcomes assessor.

It started in 2017-08-01 with completion listed for 2018-10-30.

It ran at 2 sites in China (2).

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Peripheral vascular resistance (time frame: through operation completion, an average of 6 hours).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 70 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.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Methylene blue (non-peptide stack partner) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.