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临床试验/CTRI/2018/07/015125
CTRI/2018/07/015125已完成不适用

Occurrence of postoperative delirium in patients undergoing elective surgeries under general anesthesia

LHMC DELHI1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年10月13日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Proportion of postoperative delirium in patients undergoing elective surgeries under general anesthesia.

研究概览

简要总结

Delirium is a common problem in hospitalized patients, with aprevalence of 10-24% in medical population, 37–46% in surgical population, andupto 87% in ICU patients. In individuals over 65 years of age,hospitalized for medical conditions, approximately 10% exhibit delirium onadmission, and another 10-15% may develop delirium while in hospital (DSM IV1994).In Indian population, Rudraetal(2006)recorded 15% incidence ofdelirium in elderly patients after major elective surgeries.

Delirium is an acute and fluctuating disturbance ofconsciousness with reduced ability to focus, maintain, or shift attention,accompanied by change in cognition and perceptual disturbances, along with psychomotor, emotional and sleep-wakecycle disturbances.

Delirium is not a disease, but is a symptom of manypathological conditions, such as increasing age, dementia, infections,tumors, chronic diseases, metabolic disorders, fever, and intoxication. Post-operative delirium(POD) manifests in patients who haveundergone surgical procedures and anesthesia, usually peaking within threedays. Most recover within 4 weeks, but in 50% cases it may persistlonger.      Incidence of  POD varies with patientsage, pain scores, type of surgery, degree of operative stress, lowpre-operative executive scores and depression. POD is a serious complication, associated with increasedhospital and ICU length of stay, functional decline, high medical cost, 10 fold increased risk of dementia, post-discharge institutionalization anddeath. Mortality increases by 10–20% for every 48 hours ofdelirium, chiefly from association with other postoperative complications. Inliterature, most studies are in elderly patients and very few in the youngadult population.                                                                 Hence, we decided to carry out this study for occurrence ofPOD in patients 20-60 years age, and identify risk factors that may help inearly diagnosis of Delirium and avoidance of POD.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients 20-60 years of age, of either sex.
  • Elective surgeries under general anesthesia.
  • Elective surgeries under general anesthesia + Regional/Local anesthesia.

排除标准

  • Age < 20 and > 60 years Emergency surgeries Thoracic/Cardiac/Obstetric/Orthopedic/Neurosurgery Sole Regional anesthesia/Local anesthesia Patients requiring postoperative ventilatory support Pre-existing neuropsychiatric disorder (seizures, Space occupying lesion(SOL), head injury) Patients on antipsychotic drugs and drug or alcohol abuse.

结局指标

主要结局

Proportion of postoperative delirium in patients undergoing elective surgeries under general anesthesia.

时间窗: Confusion Assessment Method (CAM) applied preoperatively , and postoperatively at 2 hours, days 1, 2 and 3. VAS score (0-100 scale) used to assess pain at all times of observation.

次要结局

  • 1. Relationship between postoperative delirium and preoperative cognitive status.(2. Relationship between postoperative delirium and intraoperative factors (hemodynamic changes, blood transfusions, duration of anesthesia) and postoperative pain scores.)

研究者

发起方
LHMC DELHI
申办方类型
Government medical college

研究点 (1)

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