Preoperative Pain and POCD in Elderly Patients | NCT03393676

Studies
Preoperative Pain and POCD in Elderly Patients

NCT03393676

Sponsor

RenJi Hospital

Status

Unknown status

Last Update Posted

Mar 10, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Postoperative Cognitive Dysfunction

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2018Actual

Primary Completion Date

Mar 31, 2020Estimated

Completion Date

Mar 31, 2020Estimated

First Submitted Date

Dec 26, 2017

First Submission Date that Met QC Criteria

Jan 5, 2018

First Posted Date

Jan 8, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2020

Last Update Posted Date

Mar 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.

Detailed Description

Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. The mechanism of POCD is not clear yet and no effective therapy method. In the present study, we conducted a single-center observational prospective cohort trial in elder patients who undergoing hip joint replacement surgery with general anesthesia to test our hypothesis that preoperative chronic pain is one of the risk factors of POCD after major joint replacement surgery.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
POCD incidence 7 days (or before leaving hospital) after surgery	POCD incidence 7 days (or before leaving hospital) after surgery	7 days (or before leaving hospital)

Secondary Outcomes

Measure	Description	Time Frame
POCD incidence 2 months after surgery	POCD incidence 2 months after surgery	2 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elder than 65 years old
Speak Chinese Mandarin
Those who will undergo major low limb surgery like hemiarthroplasty or total hip arthroplasty with general anesthesia.
Signed the inform consent
American Society of Anesthesiologists classification I to II

Exclusion Criteria:

Existing cerebral disease, or have a history of neurological and psychiatric disease including Alzheimer Disease, stroke, epilepsy and psychosis
Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
Severe hearing or visual impairment
Unwillingness to comply with the protocol or procedures
Cannot communicate with Chinese Mandarin
Serious pulmonary, heart , liver or renal insufficiency patients
Had anesthesia or surgery within the past 30 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Elderly patients underwent elective low limb surgery(hemiarthroplasty or total hip arthroplasty); Chronic pain duration >3 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaorong Huai, MS	Contact	13818003683		smile_huai@126.com
Diansan Su, MD	Contact	18616514088		diansansu@yahoo.com

Overall Officials

Name	Affiliation	Role
Weifeng Yu, MD	Anesthesiology Department Renji Hospital, Shanghai	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reni Hospital, Shanghai Jiao Tong University, School of Medicine	Recruiting	Shanghai	Shanghai Municipality	200127	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34975369	Derived	Huai X, Jiao Y, Gu X, Zhu H, Chen L, Fan Y, Yu W, Su D, Xie H. Preoperative Chronic Pain as a Risk Factor for Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: A Prospective Observational Cohort Study. Front Neurosci. 2021 Dec 17;15:747362. doi: 10.3389/fnins.2021.747362. eCollection 2021.

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D060825	Cognitive Dysfunction