The Effect of Frailty to Perioperative Complications in the Elderly

Completed

• Conditions: Fragility; Intraoperative Hypotension; Perioperative Complication

• Registration Number: NCT04120012
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2019-11-20
• Primary Completion: 2022-04-25
• Status Verified: 2022-05
• Study Completion: 2022-05-25
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative hypotension	Intraoperative	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.
Incidence of intraoperative hemodynamic instability	Intraoperative	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of postoperative complications	Within 30days after surgery	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.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China