Preoperative Pain and POCD in Elderly Patients

Postoperative Cognitive Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03393676
• Other study ID #: PPOCD20161201
• Status: Recruiting
• Start date: January 10, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2020
• Source: RenJi Hospital
• Contact: Xiaorong Huai, MS
• Phone: 13818003683
• Email: smile_huai[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
China	Reni Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai
China	Shanghai Ren ji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	POCD incidence 2 months after surgery	POCD incidence 2 months after surgery	2 months after surgery