drugset / Trial / NCT03485404
Preoperative Vitamin B12 and Folic Acid on POCD in Elderly Non-cardiac Surgical Patients
Terminated
40 enrolled
Xijing Hospital
Anhui Provincial Hospital · collabFirst Affiliated Hospital Xi'an Jiaotong University · collabShaanxi Provincial People's Hospital · collabShanghai 10th People's Hospital · collabTang-Du Hospital · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This study will recruit patients more than 65 years old eligible for non-cardiac surgery. Patients who participate will take either vitamin B12 and folic acid supplementation or placebo for 7 days before surgery. Neuropsychological test battery (NPB) will be tested before intervention and at discharge for determination of Post operative cognitive dysfunction (POCD). Another group of non-surgical elderly participants will also be tested for NPB to account for learning effect in POCD diagnosis. The hypothesis is that preoperative vitamin B12 supplementation will reduce the incidence of POCD in elderly patients undergoing non-cardiac surgery.
Timeline
- Start
- 2019-01-10
- Primary completion
- 2021-07-29
- Completion
- 2021-07-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | folic acid | Other / unclassified | 5 mg | Oral |
| Subject | methylcobalamin | Small molecule | 0.5 mg | Oral |
Indications
No indication recorded.