- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06307717
Effects of Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety in Elderly Patients
Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Chinese PLA General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Geriatric surgical patients ≥65 years old Non-selective cardiac surgery Non-neurosurgical
Exclusion Criteria:
- underwent reoperation within 7 days
- ASA classification of Ⅳ or above
- history of serious mental illness or long-term use of psychotropic drugs
- patients either died or were transferred to the intensive care unit within 7 days of the surgery
- subjects with missing covariate data
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
|
|
control
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: Depression within 7 days of surgery
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: Anxiety within 7 days of 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.
|
Anxiety within 7 days of surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: WEIDONG MI, PhD, Chinese PLA General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAGH-DA-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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