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Effect of intraoperative methylene blue on postoperative delirium in elderly patients undergoing joint replacement

Effect of intraoperative methylene blue on postoperative delirium in elderly patients undergoing joint replacement

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074038
Enrollment
Unknown
Registered
2023-07-27
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Interventions

Methylene blue group:The patients in methylene blue group receive continuous intravenous infusion of 2 mg/kg methylene blue diluted with 5% glucose solution into total 50 ml volume within 60 min imme
Control group:The patients in control group receive intravenous infusion of 50 ml of 5% glucose solution within 60 min immediately after anesthetic induction.

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients undergoing joint replacement under general anesthesia; 2. Age = 65; 3. Available for on-site follow-up interviews and willing to complete neuropsychological testing

Exclusion criteria

Exclusion criteria: 1. Preexisted dementia, major depression or other serious mental or neurological disorders ; 2. History of allergy to MB or 6-phospho-glucose dehydrogenase deficiency (favism); 3. Drug or alcohol abuse or recent drug administration that may lead to drug interactions, such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs); 4. History of major head trauma; 5. Emergency surgery; 6. Serious medical diseases (ie. heart failure, pulmonary hypertension, respiratory failure, liver and kidney dysfunctions; 7. Severe language, visual or auditory deficiency; 8. Participated in other clinical trials within 3 months; 9. Preoperative Mini-Mental State Examination (MMSE) score, illiterate (i.e., uneducated) MMSE 6 years of education) MMSE < 24 ;

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 5 days after surgery;

Secondary

MeasureTime frame
Duration and severity of delirium and type of delirium;CRSR score 10 minutes and 20 minutes after extubation;Incidence of delayed neurocognitive recovery after surgery(7-30 days);Postoperative pain score;Hospitalization time (from the day of surgery to discharge);

Countries

China

Contacts

Public ContactZhang Yueying

Affiliated Hospital of Xuzhou Medical University

zyy0218@126.com+86 180 5226 8602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026