Incidence of Postoperative Cognitive Decline in Patients With Preexisting Cognitive Impairment

NCT07135336 | Recruiting

• 1 other identifier: 2025（134）
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to find out how often memory and thinking problems happen after surgery in people who already have memory issues before their operation. These memory problems are called postoperative cognitive decline (POCD). Older adults with memory problems before surgery may be more likely to have trouble with thinking, memory, and daily activities after their operation. This study will follow patients who already have memory problems before surgery and see how their thinking and memory change after surgery. The results will help doctors better understand how to care for these patients before, during, and after surgery.

Conditions

Cognitive and Behavioral Impairment

Keywords

postoperative cognitive decline; preexisting cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Cognitive Decline (POCD) at 3 Months

  The primary outcome is the incidence of objectively measurable postoperative cognitive decline (POCD) at 3 months in patients with preexisting cognitive impairment undergoing elective non-cardiac surgery under general anesthesia. The diagnosis of POCD will follow the nomenclature recommendations by Evered et al., which define POCD as cognitive decline occurring between 3 months and 7.5 years after surgery, determined by standardized score changes compared with a normative reference population. In this study, POCD will be identified using the Reliable Change Index (RCI), calculated as: RCI = (ΔX\_patient - Δμ\_normative) / σ\_normative A patient will be diagnosed with POCD if: At least two cognitive domains show an RCI ≤ -1.96, or The combined Z-score of all cognitive tests is ≤ -1.96.

  3 months after surgery

Secondary Outcomes (5)

• Incidence of POCD at 12 Months

  12 months after surgery

• Neuropsychiatric Symptoms Assessed by NPI-Q

  3 and 12 months after surgery

• Functional Ability Assessed by The Barthel Index

  3 and 12 months after surgery

• Dementia Severity Assessed by CDR

  3 and 12 months after surgery

• Instrumental activities of daily living by The Lawton IADL

  3 and 12 months after surgery

Study Arms (2)

Preexisting Cognitive Impairment (PreCI) Group

Patients aged 60 years and older with preexisting cognitive impairment undergoing elective non-cardiac surgery under general anesthesia. These patients will receive standard perioperative care without any additional intervention. Cognitive function and neuropsychiatric status will be assessed before surgery, and at 3 and 12 months after surgery to determine the incidence of postoperative cognitive decline (POCD).

Procedure: surgery

Normative Population

Cognitively normal individuals recruited from inpatients and outpatients of Peking University Shenzhen Hospital. These participants will not undergo surgery but will complete the same cognitive assessments at baseline, 3 months, and 12 months. The normative data will be used to calculate the Reliable Change Index (RCI) for identifying clinically significant cognitive decline in the PreCI group.

Other: norma

Interventions

surgery PROCEDURE

Patients with preexisting cognitive impairment undergoing elective non-cardiac surgery under general anesthesia.

Preexisting Cognitive Impairment (PreCI) Group

norma OTHER

Cognitively normal individuals who do not undergo surgery but complete the same cognitive assessments at baseline, 3 months, and 12 months for normative reference.

Normative Population

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged 60 years and older with preexisting cognitive impairment undergoing elective non-cardiac surgery under general anesthesia at Peking University Shenzhen Hospital will be recruited between June 2025 and December 2027. A normative reference group of cognitively normal elderly individuals, matched by age and sex, will also be enrolled from the same hospital during the same period. All participants must reside in Shenzhen and be able to communicate in Mandarin.

You may qualify if:

• Age ≥ 60 years
• Preoperative screening with MMSE and MoCA-B indicating mild cognitive impairment (MCI) or mild dementia
• Undergoing elective non-cardiac surgery under general anesthesia

You may not qualify if:

• Expected difficulty in completing neuropsychological assessments (e.g., inability to communicate in Mandarin, blindness, or deafness)
• Usual residence outside Shenzhen
• Normative Reference Group
• Age ≥ 60 years
• No history of general anesthesia surgery within the past 12 months
• Mini-Cog score \> 1
• Planned elective surgery under general anesthesia within the next 12 months
• History of suspected or diagnosed cognitive impairment, or screening indicating cognitive impairment using MMSE and MoCA-B
• Expected difficulty in completing neuropsychological assessments (e.g., inability to communicate in Mandarin, blindness, or deafness)
• Usual residence outside Shenzhen

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Yaqian Yu

CONTACT

+86 13528403653; meayaqian@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: August 22, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-07

Locations

CN (1)