跳至主要内容
临床试验/NCT06964893
NCT06964893已完成不适用

The Effect of Early Postoperative Pain on Postoperative Delirium (POD) in Elderly Patients Undergoing Abdominal Surgery:a Secondary Analysis of Multicenter Prospective Data

Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 3,389 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,389
试验地点
1
主要终点
Incidence of postoperative delirium

研究概览

简要总结

This research project is an observational cohort study, representing a secondary analysis of multicenter prospective data from China spanning 2020 to 2022. The study aims to investigate the impact of moderate to severe acute pain on the first postoperative day (POD1) on delirium and anxiety and depression states in elderly patients undergoing abdominal surgery.

详细描述

Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present. the investigators collected baseline characteristics and demographic data of the patients, including clinical information in the following areas:(1) Baseline characteristics: age, gender, body mass index (BMI), American Society of Anesthesiologists (ASA) physical status score, smoke, alcohol , preoperative history of chronic pain, and comorbidities (hypertension, diabetes mellitus, coronary artery disease, cerebrovascular disease, hepatic insufficiency, and renal insufficiency).(2) Preoperative laboratory tests (the most recent prior to surgery): hemoglobin (Hb), white blood cell count, and serum albumin.(3) Preoperative psychological assessments: anxiety and depression state evaluations.(4) Intraoperative variables: grade of operation, type of surgery, duration of surgery, blood transfusion, blood loss, intraoperative dexmedetomidine and nonsteroidal anti-inflammatory drugs (NSAIDs), drain, and PCIA.In this study, the investigators defined the presence or absence of moderate-to-severe pain on POD1 as the exposure variable, assessed using the Numerical Rating Scale (NRS). An NRS score <4 on POD1 was classified as mild pain, while a score ≥4 indicated moderate-to-severe pain 8. Based on this exposure variable, patients were stratified into two groups: the mild pain group (NRS <4) and the moderate-to-severe pain group (NRS ≥4).The investigators summarized patient characteristics based on the presence or absence of moderate-to-severe pain. Continuous variables were expressed as mean ± standard deviation or median (interquartile range) and compared using t-tests or Mann-Whitney U tests. Categorical variables were presented as frequencies and percentages and compared using chi-square tests. Univariate and multivariate regression models were employed to examine the relationship between early postoperative acute pain and the incidence of POD . Furthermore, propensity score matching and subgroup analyses were conducted to further explore the association between the two.

研究设计

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

入排标准

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

入选标准

  • •Absence of hearing, visual, or cognitive impairments (operationally defined as a Chinese version of the Mini-Mental State Examination [MMSE] score ≤17);
  • •Scheduled for elective abdominal surgery;
  • •Under general anesthesia with endotracheal intubation;
  • •Completion of postoperative delirium, anxiety, and depression assessments.

排除标准

  • •History of severe psychiatric disorders or chronic use of psychotropic medications;
  • •Surgery performed via natural orifice transluminal endoscopic surgery (NOTES) approach;
  • •Undergoing vascular interventional procedures;postoperative transfer to the intensive care unit (ICU);
  • •Death within 7 days after surgery. -

结局指标

主要结局

Incidence of postoperative delirium

时间窗: within 7 days after surgery

The incidence of postoperative delirium was assessed by a 3-minute diagnostic interview in the surgical ward (3D-CAM).

Subtype of delirium episodes

时间窗: within 7 days after surgery

Confusion Assessment Method (CAM) to assess the subtype of postoperative delirium, including four features: acute change or fluctuation course of mental status; inattention; altered level of consciousness; disorganized thinking.

次要结局

  • Incidence of anxiety state(within 7 days postoperatively)
  • Incidence of depression state(within 7 days postoperatively)
  • Classification of postoperative anxiety state(within 7 days postoperatively)
  • Classification of postoperative depression state(within 7 days postoperatively)

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, Department of Anesthesiology (Cheif expert of National key research and development program of China 2018YFC2001900)

Chinese PLA General Hospital

研究点 (1)

Loading locations...

相似试验