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Preoperative Pain and POCD in Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393676
Recruitment Status : Unknown
Verified March 2020 by Xiaorong Huai, RenJi Hospital.
Recruitment status was:  Recruiting
First Posted : January 8, 2018
Last Update Posted : March 10, 2020
Sponsor:
Information provided by (Responsible Party):
Xiaorong Huai, RenJi Hospital

Study Description
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Brief Summary:
The purpose of this study is to investigate whether preoperative pain is the risk factor of POCD in elder patients.

Condition or disease
Postoperative Cognitive Dysfunction

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
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preoperative Chronic Pain Increases the Risk of Early Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Hip Joint Replacement Surgery: a Prospective Observational Cohort Study
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. POCD incidence 2 months after surgery [ Time Frame: 2 months after surgery ]
    POCD incidence 2 months after surgery


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly patients underwent elective low limb surgery(hemiarthroplasty or total hip arthroplasty); Chronic pain duration >3 months.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393676


Contacts
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Contact: Xiaorong Huai, MS 13818003683 smile_huai@126.com
Contact: Diansan Su, MD 18616514088 diansansu@yahoo.com

Locations
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China, Shanghai
Reni Hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Xiaorong Huai, MS    13818003683    smile_huai@126.com   
Contact: Diansan Su, MD    18616514088    diansansu@163.com   
Shanghai Ren ji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Xiaorong Huai, MS    +8613818003683    smile_huai@126.com   
Contact: Diansan Su, MD    +8618616514088    diansansu@yahoo.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Weifeng Yu, MD Anesthesiology Department Renji Hospital, Shanghai
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Xiaorong Huai, Dr., RenJi Hospital
ClinicalTrials.gov Identifier: NCT03393676    
Other Study ID Numbers: PPOCD20161201
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaorong Huai, RenJi Hospital:
Postoperative Cognitive Dysfunction
elderly patients
Preoperative Pain
Additional relevant MeSH terms:
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Postoperative Cognitive Complications
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
 Mental Disorders
Postoperative Complications
Pathologic Processes