Clinical trial NCT03393676: Preoperative Pain and POCD in Elderly Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Keywords: Postoperative Cognitive Dysfunction
elderly patients
Preoperative Pain
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients underwent elective low limb surgery(hemiarthroplasty or total hip arthroplasty); Chronic pain duration \>3 months.

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.

Eligibility 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

Primary outcomes:
measure: POCD incidence 7 days (or before leaving hospital) after surgery
timeFrame: 7 days (or before leaving hospital)
Secondary outcomes:
measure: POCD incidence 2 months after surgery
timeFrame: 2 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Reni Hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ren ji Hospital
state: Shanghai
Study officials:
affiliation: Anesthesiology Department Renji Hospital, Shanghai
name: Weifeng Yu, MD
role: STUDY_CHAIR
References:
citation: 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.