Clinical trial NCT06641986: A Prediction Model of Postoperative Anxiety Symptom in Elderly Patients Undergoing Major Noncardiac Surgery
Official title: Identification and Validation of a Prediction Model of Postoperative Anxiety Symptom in Elderly Patients Undergoing Major Noncardiac Surgery: a Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Predictive Model
Keywords: predicted model
major non-cardiac surgery
elderly patients
anxiety
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Peking University First Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Xiangya Hospital of Central South University
name: Beijing Anzhen Hospital
name: Central South University
name: Peking University People's Hospital
name: Zhejiang University
name: Fudan University
name: Sun Yat-sen University
name: Wuhan Union Hospital, China
name: China-Japan Friendship Hospital
name: The Affiliated Hospital Of Guizhou Medical University
name: First Affiliated Hospital of Xinjiang Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: Taihe Hospital
name: Zhejiang Provincial People's Hospital
name: Shanghai Zhongshan Hospital
First posted: 2024-10-15
Enrollment: 5551
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety
timeFrame: within 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: First Medical center of Chinese PLA General Hospital
state: Beijing
Study officials:
References: