NCT03393676

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 8, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2.2 years

First QC Date

December 26, 2017

Last Update Submit

March 8, 2020

Conditions

Keywords

Postoperative Cognitive Dysfunctionelderly patientsPreoperative Pain

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • POCD incidence 2 months after surgery

    2 months after surgery

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Reni Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai Ren ji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Weifeng Yu, MD

    Anesthesiology Department Renji Hospital, Shanghai

    STUDY CHAIR

Central Study Contacts

Xiaorong Huai, MS

CONTACT

Diansan Su, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 8, 2018

Study Start

January 10, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations