NCT06307717

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

March 6, 2024

Last Update Submit

April 9, 2024

Conditions

Keywords

AnxietyDepressionAgedSurgeryVolatile anaesthetics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Anxiety

    Anxiety within 7 days of surgery

Study Arms (2)

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.

Drug: volatile anaesthetic (sevoflurane, isoflurane, desflurane)

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.

Interventions

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.

Also known as: The blank group was without the use of any inhalation anesthetics
volatile anaesthetic (sevoflurane, isoflurane, desflurane)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

SevofluraneIsofluraneDesflurane

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • WEIDONG MI, PhD

    Chinese PLA General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

First Submitted

March 6, 2024

First Posted

March 13, 2024

Study Start

April 1, 2020

Primary Completion

October 31, 2021

Study Completion

April 30, 2022

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations