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Clinical Trials/NCT03393676
NCT03393676UnknownNot Applicable

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

RenJi Hospital2 sites in 1 country100 target enrollmentStarted: January 10, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Locations
2
Primary Endpoint
POCD incidence 7 days (or before leaving hospital) after surgery

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • POCD incidence 2 months after surgery(2 months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xiaorong Huai

Dr.

RenJi Hospital

Study Sites (2)

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