Preoperative Pain and POCD in Elderly Patients

March 8, 2020 updated by: Xiaorong Huai, RenJi Hospital

Preoperative Chronic Pain Increases the Risk of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: a Prospective Observational Cohort Study

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

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Reni Hospital, Shanghai Jiao Tong University, School of Medicine
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Ren ji Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Study Chair: Weifeng Yu, MD, Anesthesiology Department Renji Hospital, Shanghai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2018

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

March 31, 2020

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 8, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPOCD20161201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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