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临床试验/NCT06307717
NCT06307717已完成不适用

Volatile Anaesthetics on Incidence of Postoperative Depression and Anxiety

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 8,000 人开始时间: 2020年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
8,000
试验地点
1
主要终点
Depression

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: volatile anaesthetic (sevoflurane, isoflurane, desflurane) (Drug)

结局指标

主要结局

Depression

时间窗: 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.

次要结局

  • Anxiety(Anxiety within 7 days of surgery)

研究者

发起方
Chinese PLA General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Weidong Mi

Director (Cheif expert of National key research and development program of China 2018YFC2001900)

Chinese PLA General Hospital

研究点 (1)

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