Effects of Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety in Elderly Patients

Cohort Studies Clinical Trial

Official title:

Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06307717
• Other study ID #: PLAGH-DA-002
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2024
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is a retrospective analysis of a large-scale multicentre prospective cohort study that investigates the impact of volatile anaesthetics on the incidence of postoperative depression and anxiety among elderly patients.

Description:

Studies have suggested volatile anaesthetics may alleviate depression and anxiety in patients. However, there is a paucity of research in this area. The investigatorswanted to determine the association between volatile anaesthetics and depression/anxiety in elderly patients within 7 days after surgery.

This study retrospectively analysed data from a prospective database of patients aged 65 and above who underwent non-cardiac, non-neurosurgical elective surgery in 18 tertiary hospitals across 10 provinces in China. Patients receiving volatile anaesthetics received at least one volatile anaesthetic (sevoflurane, isoflurane, desflurane), and those who received non-volatile anaesthetics did not receive any volatile anaesthetic. Binary logistic regression analyses were conducted, and propensity score-matching (PSM) and subgroup analyses were also applied.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8000
• Est. completion date: April 30, 2022
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Geriatric surgical patients =65 years old Non-selective cardiac surgery Non-neurosurgical

Exclusion Criteria:

1. underwent reoperation within 7 days

2. ASA classification of ? or above

3. history of serious mental illness or long-term use of psychotropic drugs

4. patients either died or were transferred to the intensive care unit within 7 days of the surgery

5. subjects with missing covariate data

Related Conditions & MeSH terms

• Cohort Studies
• Depression

Intervention

Drug:
• volatile anaesthetic (sevoflurane, isoflurane, desflurane)
Patients receiving volatile anaesthetics received at least one volatile anaesthetic (sevoflurane, isoflurane, desflurane), and those who received non-volatile anaesthetics did not receive any volatile anaesthetic.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (17)

Lead Sponsor

Collaborator

Chinese PLA General Hospital

Beijing Anzhen Hospital, Beijing Tsinghua Changgeng Hospital, Central South University, China-Japan Friendship Hospital, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Xinjiang Medical University, Fudan University, Peking University First Hospital, Peking University People's Hospital, Sun Yat-sen University, Taihe Hospital, The Affiliated Hospital Of Guizhou Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Wuhan Union Hospital, China, Xiangya Hospital of Central South University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Primary outcomes were depression Patient Health Questionnaire 9 (PHQ-9).The PHQ-9 is a nine-item questionnaire for screening on the presence of depressive symptoms and monitoring depression severity. Items were scored on a four-point scale with total scores ranging from zero to twenty-seven. Scores were defined as: =5 mild, =10 moderate, and =15 severe level of depression. The recommended screening cutoff was =10, corresponding with at least a moderate level of depression. The higher the score, the worse the situation. The total score ranges from 0 to 27, and higher scores indicate more depressive symptoms.	Depression within 7 days of surgery
Secondary	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.	Anxiety within 7 days of surgery