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NCT Number: NCT07314762

Elderly Patients Undergoing Surgery During Perioperative Period

The elderly patients have poorer overall conditions and have lower tolerance to trauma, anesthesia, and surgery. Therefore, the incidence of postoperative complications is relatively higher. In non-cardiac surgeries, approximately 20% of elderly patients experience postoperative complications, and the incidence of postoperative delirium (POD) is 23.8%. This may lead to prolonged hospital stays, increased hospital costs, and affect prognosis and even mortality. The investigators plan to conduct a prospective cohort study by systematically collecting biological samples and clinical information of elderly patients during the perioperative period to explore the possible risk factors and pathogenesis of postoperative delirium and postoperative complications in elderly surgical patients, and to construct a risk prediction model for postoperative complications.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Ting Li MD.PhD

CONTACT

[email protected]

0577-88002888

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Surgical patients aged 65 or above or non-surgical subjects aged 65 or above. 2) Agree to participate in this study and sign the informed consent form.

Exclusion criteria

1)Refused to participate in the study.

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative delirium (POD) within 7 days after surgery

    Time frame: Preoperative, during the first 7 postoperative days

    POD is diagnosed daily using the Three-Minute Diagnostic Confusion Assessment Method (3D-CAM).

Secondary outcomes

  1. The types of postoperative delirium

    Time frame: Preoperative, during the first 7 postoperative days

    The type of delirium is assessed using the Richmond Agitation-Sedation Scale (RASS). The Richmond Agitation-Sedation Scale (RASS) is a 10-point scale ranging from -5 (unarousable) to +4 (combative). A score of +4 represents a combative state where the patient is violent and poses immediate danger, while a score of -5 indicates no response to any stimulus. Based on the RASS score, delirium can be categorized into three motoric subtypes: Hyperactive delirium: RASS scores consistently between +1 and +4. Hypoactive delirium: RASS scores consistently between 0 and -3. Mixed-type delirium: RASS scores that fluctuate between positive and negative values over the observation period.

  2. The severity of postoperative delirium

    Time frame: Preoperative, during the first 7 postoperative days

    The severity of postoperative delirium will be assessed using the Confusion Assessment Method-Severity scale (CAM-S).

  3. The duration of postoperative delirium

    Time frame: Preoperative, during the first 7 postoperative days

    Duration is defined as the number of days from the onset of delirium symptoms to symptom resolution or hospital discharge, whichever occurs first.

  4. Postoperative neurocognitive dysfunction

    Time frame: preoperative baseline, within 7 days postoperatively, and at 1, 6, and 12 months postoperatively.

    Neurocognitive decline is assessed by comparing baseline to postoperative scores on: Mini-Mental State Examination (MMSE, 0-30, higher=better function), Montreal Cognitive Assessment (MoCA, 0-30, higher=better function); and five neuropsychological tests-Clock Drawing Test, (DST, 0-16, higher=better attention), Trail Making Test Parts A and B (TMT-A/B, seconds, lower=better), Boston Naming Test (BNT, 0-30, higher=better naming), Auditory Verbal Learning Test - Huashan version (AVLT-H delayed recall, 0-10, higher=better memory), and Clock Drawing Test (CDT, 0-10, higher=better visuospatial/executive function). Patient/caregiver reports are also collected.

  5. Acute pain

    Time frame: Preoperative and 3 days postoperative.

    Using Visual Analogue Scale (VAS), 0-100, 0 means no pain, 100 means severe pain

  6. Hospital Anxiety and Depression Scale (HADS) score

    Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.

    The Hospital Anxiety and Depression Scale (HADS) is used for assessment, with each subscale (anxiety or depression) scored from 0-21: "0-7: Non-case", "8-10: Doubtful case", "11-21: Definite case". Higher scores clearly indicate worse outcomes, i.e., more severe anxiety or depression symptoms.

  7. Activity of Daily Living

    Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.

    The Activities of Daily Living (ADL) are typically assessed using the Barthel Index. 0-100. A higher score indicates stronger independence: a score of 100 represents complete independence; a score of 61-99 suggests mild functional impairment with basic self-care ability; and a score of ≤40 indicates severe functional impairment, with significant or complete reliance on others for daily living.

  8. Sleep quality

    Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.

    Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 to 21 points. A score greater than 7 (>7) is typically considered the clinical cutoff for poor sleep quality. A higher score indicates poorer sleep quality.

  9. The FRAIL Scale

    Time frame: preoperative, 5 days, 1 month, 6 months, and 1 year postoperative.

    The FRAIL (Fatigue, Resistance, Ambulation, Illnesses, and Loss of Weight) Scale ranges from 0 to 5. A score of 0 indicates robust/non-frail status, scores of 1-2 indicate pre-frail status, and scores of 3-5 indicate frail status.

  10. Quality of Life Score

    Time frame: preoperative, 1 month, 6 months, and 1 year postoperative.

    using EQ-5D(Score of EuroQol Five Dimensions Questionnaire (EQ-5D)) to measure quality of life

  11. Mortality

    Time frame: During hospitalization, 1 month, 6 months, and 1 year postoperative.

    In-hospital mortality; 30-day postoperative mortality; 1-year postoperative mortality

  12. Length of hospitalization

    Time frame: till the day of discharge from hospital, an average of 7 days

    Length of hospital stay are measured from the anesthesia starting day to the discharge day

  13. Days at home up to 30 days after surgery (DAH30)

    Time frame: up to 30 days after surgery

  14. Economic indicators

    Time frame: during the entire trial, an average of 1 year.

    Hospitalization fees; -Preoperative fees; -Anesthesia fees; -Surgery fees; -Post-operative fees; -Post-discharge medical expenses.

Study contacts

Contact information is provided by the study sponsor or research team.

Ting Li MD. PhD

CONTACT

[email protected]

+86-135-8787-6896

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Wenzhou Medical University

Other

Registry information

Official study title

Elderly Patients Undergoing Surgery During Perioperative Period: a Prospective Cohort Study

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jan 2, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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