Trials Sponsors Conditions Drugs Pricing

Conditions

Post Operative Cognitive Dysfunction

Keywords

POCDvitamin B12folic acid

Outcome Measures

Primary Outcomes (1)

Incidence of POCD at discharge or 7 days after operation
POCD incidence is defined as two or more test of the neuropsychological battery declined as compared to preoperative baseline.
at discharge or at 7 days after operation if the patient is not discharged by then

Secondary Outcomes (5)

Activity daily living score
3 months after operation
Serum level of vitamin B12, folic acid and homocysteine
Immediately before anesthesia, immediately after surgery and on the morning of postoperative day 1
Serum level of cystatin C and myeloid differentiation protein 2
Immediately before anesthesia, immediately after surgery and on the morning of postoperative day 1
Length of hospital stay
Date from hospital admission to hospital discharge. This length is usually around 7-14 days. It may be longer if the patient have one or more complications. The length will be documented at patient discharge, up to 100 weeks.
Incidence of in hospital complications
From date of hospital admission to date of hospital discharge after surgery. Usually 7-14 days, assessed up to 100 weeks.

Study Arms (3)

VB12+FA

EXPERIMENTAL

Patients will receive oral supplementation of 0.5mg methylcobalamin, 3/day and 5 mg folic acid, 1/day for 7 days before non-cardiac surgery.

Drug: methylcobalaminDrug: Folic AcidProcedure: non-cardiac surgeryBehavioral: NPB test

Placebo

PLACEBO COMPARATOR

Patients with receive oral tablets of placebo for folic acid 1/d and placebo for methylcobalamin 3/d, which look exactly like the interventional drugs as oral supplementation for 7 days before non-cardiac surgery.

Other: Placebo for methylcobalaminOther: Placebo for folic acidProcedure: non-cardiac surgery

Interventions

methylcobalaminDrug

methylcobalamin tablets, 0.5mg/tablet, 3 tablets/day.

Also known as: vitamin B12, VB12

VB12+FA

Folic AcidDrug

folic acid tablets, 5mg/tablet, 1 tablet/day

Also known as: vitamin B9

Eligibility Criteria

Age65 Years+

Sexall

Healthy VolunteersNo

Age GroupsOlder Adult (65+)

You may qualify if:

\. Age equals or over 65
\. Scheduled for spinal or joint replacement surgery under general anesthesia，estimated surgery time over 2h.

Sponsors & Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Othercollaborator
Tang-Du Hospital
Othercollaborator
Shaanxi Provincial People's Hospital

Study Sites (13)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Shenzhen University General Hospital

Shenzhen, Guangdong, China

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710032, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, 710032, China

MeSH Terms

Interventions

mecobalaminVitamin B 12Folic Acid

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic CompoundsPterinsPteridines

Study Officials

Lize Xiong, M.D., Ph.D.
Xijing Hospital
STUDY CHAIR

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, CARE PROVIDER
Masking Details: Central randomization. Groups are marked as A and B with no participants, care provider, investigator and outcome assessors know which group is the drug and which is the placebo. Placebo are made as tablets that mimics the color, shape and size of the drugs.
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

March 7, 2018

First Posted

April 2, 2018

Study Start

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

VB12+FA

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Non-surgical controls

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

VB12+FA

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Non-surgical controls

You may not qualify if:

Source record

Locations