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

• Status: Completed
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

Summary

Postoperative neurocognitive impairments often occur in elderly patients undergoing anesthesia and non-cardiac surgery, including postoperative delirium (POD) and postoperative cognitive dysfunction (POCD). These disorders are often associated with increased mortality and morbidity, prolonged length of hospital stay, functional and cognitive decline with nursing home or long-term care facility placement. Until now highly effective intervention has not been established yet. As a mitochondrial protective agent, the role of methylene blue(MB) in preventing elderly patients from POD/POCD is unknown.Therefore, investigators design this study to validate its prevention against POD/POCD and the aim of this study is to evaluate the efficacy and safety of perioperative administration of MB for POD/POCD prevention.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Anesthetics; Methylene Blue

Criteria

Inclusion Criteria:

• 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

• MMSE>20

• 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.

Exclusion Criteria:

• Patients with personal history of allergy to methylene blue

• Emergency Surgery

• Patients have 6-phospho-glucose dehydrogenase deficiency (vicia faba disease)

• Patients have recent drug administration that may lead to drug interactions(e.g..SSRIs, SNRIs)

• Patient with a history of major head trauma

• Patients with a history of drug or alcohol abuse

• Patient has serious mental or neurological disorders

• Patients with severe language, hearing and visual impairment

• Patients have serious medical diseases(e.g..heart failure, acute stage of myocardial infarction or respiratory failure)

• Illiteracy

• Patients have participated in other clinical trials in the last 3 months.