Efficacy and safety of gastrodin Injection in the prevention of delirium and cognitive dysfunction after hip or knee arthroplasty: a randomized, double-blind and placebo-controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018397

Enrollment

Unknown

Registered

2018-09-15

Start date

2018-09-17

Completion date

Unknown

Last updated

2018-09-17

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

Conditions

Postoperative cognitive dysfunction?delirium

Interventions

experimental group:gastrodin Injection

control group :placebo

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent; 2. Patients with hip or knee arthroplasty, aged years =60 years, Patients of both genders; 3. ASA II to IV; 4. MMSE>24; 5. Education years =6.

Exclusion criteria

Exclusion criteria: 1. The drug history of gastrodin injection in the past 1 month; 2. Allergic to gastrodia, gastrodin and its excipients; 3. History of schizophrenia, epilepsy, Parkinson's syndrome or myasthenia gravis; 4. Unable to communicate before operation (coma, severe dementia or language disorder); 5. Brain injury or neurosurgical history and central nervous system disease; 6. Preoperative left ventricular ejection fraction is known to be less than 30%, Sick sinus syndrome, severe sinus bradycardia (<50 times/min [BPM]),or secondary or greater atrioventricular block without a pacemaker; 7. Severe liver dysfunction or severe renal insufficiency (dialysis before surgery); 8. Uncontrolled diabetes or hypertension; 9. Severe visual or hearing impairment; 10. Less than 6 years education; 11. Use of sedatives; 12. History of alcoholism or drug dependence; 13. Expected survival period < 24h; 14. Has received any other experimental drug treatment or participated in another interventional clinical trial within 3 months prior to screening; 15. Compliance is poor and cannot be completed according to the plan; 16. Conditions that other researchers considered unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame
Cognitive function;Delirium;	—

Secondary

Measure	Time frame
pain;sleep quality;Intubation time, length of stay in PACU or ICU, postoperative hospital stay;	—

Countries

China

Contacts

Public ContactHongtao Tian

Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

kpcyxx@163.com+86 18918979301

Outcome results

None listed

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