A Prediction Model of Postoperative Anxiety Symptom in Elderly Patients Undergoing Major Noncardiac Surgery

Completed

• Conditions: Predictive Model

• Registration Number: NCT06641986
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

A multicentre, prospective observational study to develop and validate a predictive model for postoperative anxiety symptoms in elderly Chinese patients undergoing non-cardiac major surgery.

Detailed Description

In 2015, the WHO introduced the concept of "healthy ageing" for global ageing, with a focus on the mental health of older people at its core. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Previous studies have found high risk of anxiety in older perioperative patients, especially for non-cardiac major surgery patients. Therefore, it is necessary to construct a predictive model of anxiety in elderly patients undergoing non-cardiac major surgery.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2024-08
• Study First Submitted: 2024-10-13
• Study First Submitted QC: 2024-10-13
• Last Update Submitted: 2024-10-13
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5551

Inclusion Criteria

1. Elderly patients (age ≥ 65 years).
2. Undergoing elective surgery with a planned overnight hospital stay following surgery.
3. Major non-cardiac surgery, non-neurosurgical surgery.

Exclusion Criteria

1. History of previous severe mental illness or long-term use of psychotropic medications.
2. Immediately admitted to ICU after surgery.
3. Death within 7 days after surgery.
4. Grade of surgery ≤ 2.
5. Failure to complete the postoperative anxiety assessment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety	within 7 days after surgery	The GAD-7 is a seven-item questionnaire for screening on the presence of generalized anxiety disorder and assessing its severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-one. Scores were defined as: ≥5 mild, ≥10 moderate, and ≥15 severe anxiety. The recommended screening cutoff was ≥10, corresponding with at least a moderate level of anxiety. Higher scores mean more anxiety.

Trial Locations

Locations (1)

First Medical center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China