The Incidence, Risk Factors and Outcome of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 3
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium (POD) is the most common adverse neurologic complication that can occur in patients of any age. Its incidence varies across age groups and is substantially influenced by patient-related risk factors. POD occurs in 17%-61% of major surgical procedures. Several risk factors which contribute to the development of POD include age more than 60 years, pre-existing cognitive dysfunction, presence of comorbidities, sensorial deficits, malnutrition, polypharmacy, impaired physical mobility and frailty. Postoperative delirium has several wide ranging and adverse outcomes that are consistently associated with delirium such as mortality, increased length of hospital stay, and increased hospital costs. A recently devised tool for rapid assessment of delirium is the 4 A's test. It has now been validated for identifying delirium in the surgical population. The proposed prospective observational study will be conducted on 150 patients belonging to ASA Physical Status I-III of either sex, scheduled to undergo non-cardiac surgery under general anaesthesia (GA), requiring at least 24 hours of postoperative inpatient care. This prospective, observational study aims to evaluate the incidence, risk factors and outcomes of postoperative delirium in elderly patients more than 65 years of age undergoing non-cardiac surgery.
详细描述
The incidence of postoperative delirium (POD) following major surgery ranges from 17% to 61%.POD is the most frequent neurological complication that can occur in both the young and old, and its rate is considerably impacted by patient-related risk issues. The elderly population is believed to be more susceptible to POD, by virtue of being host to conditions such as a variety of comorbidities, malnutrition, concurrent cognitive dysfunction, frailty, sensorial and functional deficits, and polypharmacy.
Risk factors for delirium may be further identified as predisposing factors and precipitating factors. Predisposing factors are those that are present on admission and are not changeable, e.g. age, number and severity of co-morbid medical conditions, sensory impairment, history of cognitive impairment, sleep deprivation, immobility, and dehydration.Precipitating factors are those that trigger delirium while the patient is hospitalized. These may be infections, constipation, bladder catheterisation, procedures involving instrumentation, immobility, and sensory impairment
Postoperative delirium, especially in the elderly, significantly compromises patient recovery and imposes a heavy toll on patient well-being and the healthcare system. Postoperative delirium has several wide-ranging and adverse outcomes associated with it, such as mortality, increased length of hospital stay and increased hospital costs.
Several tools have been developed to track changes in mental status that could point to the onset of delirium. Among the tools employed for this purpose are the Sedation Scale, the Nursing-Delirium Screening Scale (Nu-DESC), and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
However, there is a lack of consensus on the use of an appropriate tool to evaluate delirium in the postoperative period. The 4A's test is a screening instrument that has been designed for rapid and initial assessment of delirium. It has the added advantage of evaluating not only delirium but also postoperative cognitive dysfunction (POCD) which is the second most common complication in elderly surgical patients.
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
- 否
入选标准
- •Patients of age >65yrs
- •Either sex
- •ASA physical status I - III
- •Elective non-cardiac surgical procedures under general anesthesia
- •Clinical Frailty Score (CFS): 1-8
- •Patients requiring at least 24 hours of postoperative inpatient care.
排除标准
- •Clinical Frailty Score (CFS) of 9
- •Patients diagnosed with dementia, severe psychiatric or neurological diseases
- •Recent surgery within past 3-months
- •History of recent head injury in the preceding 3 months
- •Patients with uncompensated cardiovascular disease, hepato-renal insufficiency and uncontrolled endocrine disease
- •Patients on anti-depressant, anti-anxiety, anti-convulsant and anti-parkinsonism medications
- •Preoperative haemoglobin < 8 gm % and serum albumin < 3.5mg/dl
- •Patient inability to give informed consent
- •Presence of preoperative delirium as assessed by 4A'S Test (score ≥ 4)
研究组 & 干预措施
Elderly
Patients > 65 years age undergoing non-cardiac surgery will be administered general anesthesia maintained with sevoflurane or desflurane titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
干预措施: Sevoflurane (Drug)
Elderly
Patients > 65 years age undergoing non-cardiac surgery will be administered general anesthesia maintained with sevoflurane or desflurane titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
干预措施: Desflurane (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: From end of surgery till 24 hours postoperatively
Postoperative delirium will be assessed using 4 A's test.A score of 0 suggests absence of delirium or severe cognitive impairment, score 1-3 suggests presence of possible cognitive impairment, and a score \> 4 suggests the presence of delirium/ cognitive impairment
次要结局
- Postoperative Sedation(From end of surgery till 24 hours postoperatively)
- Postoperative nausea and vomiting(From end of surgery till 24 hours postoperatively)
- Length of hospital stay(From end of surgery till discharge from the hospital)
- Unanticipated intensive care unit (ICU) admission(From end of surgery till 30 days postoperatively)
- Postoperative Pain(From end of surgery till 24 hours postoperatively)
- Mortality(From end of surgery till 30 days postoperatively)
研究者
Nitin Sethi, DNB
Senior Consultant & Associate Professor
Sir Ganga Ram Hospital