Incidence of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery (NCT04707794) | Clinical Trial Compass
RecruitingNot Applicable
Incidence of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery
India270 participantsStarted 2021-01-14
Plain-language summary
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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of postoperative delirium
Timeframe: From end of surgery till 24 hours postoperatively