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

Identification and Validation of a Prediction Model of Postoperative Anxiety Symptom in Elderly Patients Undergoing Major Noncardiac Surgery: a Prospective Multicenter Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Predictive Model

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 Type: Observational
• Enrollment (Actual): 5551

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, China
      • First Medical center of Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients (aged ≥ 65 years) who completed the anxiety and depression assessment after the elective major noncardiac, non-neurosurgical surgery were included in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elderly patients; elderly patients undergoing major non-cardiac surgery (aged ≥ 65 years)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	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.	within 7 days after surgery

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Peking University First Hospital; Xiangya Hospital of Central South University; Peking University People's Hospital; Sun Yat-sen University; Fudan University; Beijing Tiantan Hospital; Shanghai Zhongshan Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Beijing Anzhen Hospital; China-Japan Friendship Hospital; Wuhan Union Hospital, China; Central South University; Zhejiang University; The Affiliated Hospital Of Guizhou Medical University; Zhejiang Provincial People's Hospital; First Affiliated Hospital of Xinjiang Medical University; Taihe Hospital; First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: October 13, 2024
• First Submitted That Met QC Criteria: October 13, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 13, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: anxiety; elderly patients; predicted model; major non-cardiac surgery
• Other Study ID Numbers: PLAGH-AN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No