The Effect of Frailty to Perioperative Complications in the Elderly

Study Overview
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Brief Summary
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With the progression of population aging, the number of elderly patients undergoing surgery is increasing as well. However, as the condition of health differs greatly between individual elderly patients even of the same age, it is a necessity to evaluate elderly patients thoroughly and individually for better management of perioperative care. Frailty is a condition in which patients are impaired at physical reserve and homeostatic control. Frail elderly people are at higher risk of morbidity and mortality after exposure to a stressor. Frail patients are at higher risk of perioperative complications and longer hospital stay. However, there has been no standard criteria or tool to evaluate frailty in the elderly. Neither has there been enough evidence explaining the mechanism between frailty and increased perioperative complications. Therefore, in this study we aim to discover the relationship between frailty and intraoperative hemodynamic instability, as well as perioperative complications in the elderly patients, hoping to find an adequate and practical model for preoperative assessment in the elderly hopefully for better perioperative outcome.

Official Title
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The Effect of Frailty to Intraoperative Hemodynamic Instability and Perioperative Complications in the Elderly: a Prospective Observational Study

Conditions
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Fragility, Intraoperative Hypotension, Perioperative Complication

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age≥65 years elective major non-cardiac surgery general anesthesia American Society of Anesthesiologists(ASA) grade I,II,III study protocol fully understood by the patients, written consent obtained Exclusion Criteria: emergency surgery in active state of infection or inflammation chronic kidney disease(CKD) stage 5 having conditions that would interfere accurate measurement of upper extremity blood pressure (e.g. subclavian artery stenosis) having conditions that would interfere assessment of frailty assessment (e.g. mental disorder, hearing disorder) study protocol not fully understood, no written consent obtained

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative hypotension | Intraoperative hypotension includes post induction hypotension(PIH), early intraoperative hypotension(eIOH) and late intraoperative hypotension(lIOH). Hypotension is defined as a systolic blood pressure less than 90mmHg or a relative decrease more than 30% compared to baseline blood pressure, or mean arterial pressure less than 65mmHg or a decrease more than 30% compared to baseline. PIH is defined as a hypotension within 20 minutes after anesthesia induction, or before surgical incision. eIOH is defined as hypotension within 30 minutes after the start of surgery. lIOH is defined as hypotension that happen 30 minutes after the start of surgery until the end of surgery. | Intraoperative | 
| Incidence of intraoperative hemodynamic instability | Intraoperative hemodynamic instability is defined as a definite change of systolic blood pressure, or mean arterial pressure, or diastolic pressure, or pulse pressure more than 15% or the need for vasoactive agents. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative complications | Postoperative complications will be recorded according to medical records and laboratory results within 30 days after surgery according to Clavien-Dindo classification of surgical complications. Incidence of each grade will be calculated as outcome. Postoperative acute kidney injury will be assessed by analysis of urinary and serum biomarkers before and after surgery. | Within 30days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Intraoperative Hypotension, Perioperative Complication, Elderly