drugset
drugset / Trial / NCT03485404

Preoperative Vitamin B12 and Folic Acid on POCD in Elderly Non-cardiac Surgical Patients

NCT03485404 ↗

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

Outcome

Outcome not reported

Stopped (Enrollment): “Due to slow recruiment. Only 40 patients were recruited in four years.”

Drugs

EvaluationDrugModalityDoseRoute
Subject folic acid Other / unclassified 5 mg Oral
Subject methylcobalamin Small molecule 0.5 mg Oral

Indications

No indication recorded.