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Methylene Blue and Postoperative Neurocognitive Disorders

NCT04529265 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2025-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Delirium

Interventions

DRUG

Methylene Blue

Intraoperative infusion of 2mg/kg MB after induction of anesthesia for 1 h and 1mg/kg MB with 30 min before the end of surgery

DRUG

Placebo

Equal volume of normal saline after induction of anesthesia for 1 h and Equal volume of normal saline within 30 min before the end of surgery

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Jun Zhang, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-04-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529265 on ClinicalTrials.gov