Elderly Patients Undergoing Surgery During Perioperative Period

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Surgical patients aged 65 or above or non-surgical subjects aged 65 or above

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,200 Participants
are grouped into 2 trial groups
Group A: Surgical patients aged 65 years or older
Group B: non-surgical subjects aged 65 years or older

Trial outcomes

Primary outcomes

1

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

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

Time frame
Preoperative, during the first 7 postoperative days

Secondary outcomes

1

The types of postoperative delirium

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.

Time frame
Preoperative, during the first 7 postoperative days
2

The severity of postoperative delirium

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

Time frame
Preoperative, during the first 7 postoperative days
3

The duration of postoperative delirium

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

Time frame
Preoperative, during the first 7 postoperative days
4

Postoperative neurocognitive dysfunction

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.

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

Other outcomes

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