Incidence of Postoperative Cognitive Decline in Patients With Preexisting Cognitive Impairment

NCT ID: NCT07135336

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 340 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2027-07-01

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.

Detailed Description

This is a single-center, prospective, single-arm cohort study designed to estimate the incidence of postoperative cognitive decline (POCD) in patients aged 60 years and older with preexisting cognitive impairment undergoing elective non-cardiac surgery under general anesthesia.

To calculate the incidence of POCD, a normative population of cognitively normal individuals will be recruited to provide reference data for the expected range of cognitive change over time in the absence of surgery. This normative sample is not a control group for intervention comparison but is used to establish population-based norms for cognitive test score changes.

Study Procedures:

Preoperative assessment (1 day before surgery):

Patients will be screened using the Mini-Cog test. Those with scores ≤1 will be further evaluated with the Mini-Mental State Examination (MMSE) and Beijing version of the Montreal Cognitive Assessment (MoCA-B).（This threshold is based on the Chinese expert consensus scoring criteria, which differ slightly from the international standard. According to the Chinese algorithm, a score of ≤1 encompasses cases where the clock drawing is incorrect and one to two words are recalled, or when no words are recalled at all, aligning functionally with a score of ≤2 in the international system. Therefore, our inclusion criterion of ≤1 under the Chinese system is equivalent in diagnostic implication to the widely accepted international cutoff of ≤2, which indicates high likelihood of cognitive impairment.) Eligible participants will be enrolled after informed consent is obtained. Neuropsychiatric symptoms will be assessed using the Neuropsychiatric Inventory-Questionnaire (NPI-Q). Dementia severity and functional ability will be evaluated using the Clinical Dementia Rating (CDR), Basic Activities of Daily Living (BADL), and Instrumental Activities of Daily Living (IADL) scales.

Intraoperative data collection:

Information regarding surgery and anesthesia will be obtained from the electronic medical records.

Postoperative follow-up (at 3 and 12 months):

All participants will undergo cognitive assessments using the MMSE and MoCA-B. Neuropsychiatric symptoms, dementia severity (if applicable), and functional abilities will also be reassessed. Follow-up will be scheduled to minimize participant burden, and home-based assessments will be arranged when necessary. Remote assessments will be documented if used.

Normative Population:

Cognitively normal individuals will be recruited from inpatients and outpatients of Peking University Shenzhen Hospital. They will undergo cognitive assessments at baseline, 3 months, and 12 months to provide normative data for the calculation of standardized cognitive changes.

Primary Outcome:

The primary outcome is the incidence of POCD at 3 months after surgery. Following the nomenclature recommendations by Evered et al., POCD is defined as objectively measurable cognitive decline occurring between 3 months and 7.5 years after surgery. The diagnosis of POCD in this study will be based on the Reliable Change Index (RCI), a standardized statistical method that accounts for normal variability and practice effects over time.

RCI is calculated as:

RCI = (ΔX_patient - Δμ_normative) / σ_normative

Where ΔX_patient is the individual's change score, Δμ_normative is the mean change in the normative group, and σ_normative is the standard deviation of change scores in the normative group.

A patient will be considered to have POCD if either:

At least two cognitive domains show an RCI ≤ -1.96, or

The combined Z-score of all cognitive tests is ≤ -1.96.

Follow-up Management and Missing Data Handling:

Participants will be followed at 3 and 12 months. If a participant is unable to attend, alternative arrangements will be made. Loss to follow-up will be documented with reasons, and missing data will be addressed using sensitivity analyses.

Conditions

Cognitive and Behavioral Impairment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

surgery

Intervention Type: PROCEDURE

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

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.

norma

Intervention Type: 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.

Interventions

surgery

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

Intervention Type: PROCEDURE

norma

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Age ≥ 60 years
• No history of general anesthesia surgery within the past 12 months
• Mini-Cog score > 1

Exclusion Criteria

• Expected difficulty in completing neuropsychological assessments (e.g., inability to communicate in Mandarin, blindness, or deafness)
• Usual residence outside Shenzhen

2. Normative Reference Group

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University Shenzhen Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yaqian Yu

Role: CONTACT

meayaqian@gmail.com

+86 13528403653

Facility Contacts

Yaqian Yu

Role: primary

meayaqian@gmail.com

+86 13528403653

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2025（134）

Identifier Type: -

Identifier Source: org_study_id