Skip to content

Efficacy and safety of gastrodin Injection (Tian Xuanqing) in the prevention of perioperative neurocognitive disorders with coronary artery bypass surgery: a randomized, double-blind and placebo-controlled clinical trial

Efficacy and safety of gastrodin Injection (Tian Xuanqing) in the prevention of perioperative neurocognitive disorders with coronary artery bypass surgery: a randomized, double-blind and placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020414
Enrollment
Unknown
Registered
2018-12-28
Start date
2018-12-27
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

perioperative neurocognitive disorders

Interventions

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Sign the informed consent; 2. Patients with coronary artery bypass grafting, Aged 18-75 years old, Patients of both genders; 3. NYHA class II-III; 4. ASA I to III; 5. MMSE>24; 6. Education years =6; 7. Patients can complete the TEST of Cantab.

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 cerebrovascular disease, stroke, epilepsy, Parkinson's disease, mental illness, 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. Coagulation dysfunction; 7. Preoperative infection; 8. Tumor patients; 9. Severe liver dysfunction or severe renal insufficiency (dialysis before surgery); 10. Uncontrolled diabetes or hypertension; 11. Severe visual or hearing impairment; 12. Less than 6 years education; 13. Use of sedatives; 14. History of alcoholism or drug dependence; 15. Expected survival period < 24h; 16. Has received any other experimental drug treatment or participated in another interventional clinical trial within 3 months prior to screening; 17. Compliance is poor and cannot be completed according to the plan; 18. Conditions that other researchers considered unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Cognitive function;Delirium;

Secondary

MeasureTime frame
Depression;Anxiety;Intubation time, CPB bypass time, duration of aorta block, length of stay in ICU, postoperative hospital stay;Cognitive function;Activity of Daily Living;

Countries

China

Contacts

Public ContactQingping Wu

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

wqp1968@163.com+86 13971605283

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026