Clinical trial

The Incidence, Risk Factors and Outcome of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Prospective Observational Study

Name
EC/12/20/1763
Description
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.
Trial arms
Trial start
2021-01-14
Estimated PCD
2024-08-01
Trial end
2024-09-01
Status
Recruiting
Treatment
Sevoflurane
Sevoflurane delivery will will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
Arms:
Elderly
Desflurane
Desflurane delivery will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
Arms:
Elderly
Size
270
Primary endpoint
Incidence of postoperative delirium
From end of surgery till 24 hours postoperatively
Eligibility criteria
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)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 270, 'type': 'ESTIMATED'}}
Updated at
2023-12-12

1 organization

2 products

1 indication

Product
Desflurane