Incidence of Postoperative Cognitive Decline in Surgical Patients With Preexisting Cognitive Impairment: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Cognitive Decline (POCD) at 3 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Expected difficulty in completing neuropsychological assessments (e.g., inability to communicate in Mandarin, blindness, or deafness)
- •Usual residence outside Shenzhen
- •Normative Reference Group
- •Inclusion Criteria:
- •Age ≥ 60 years
- •No history of general anesthesia surgery within the past 12 months
- •Mini-Cog score > 1
- •Exclusion Criteria:
- •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
结局指标
主要结局
Incidence of Postoperative Cognitive Decline (POCD) at 3 Months
时间窗: 3 months after surgery
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.
次要结局
- 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)