About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients of age >65yrs
Either sex
ASA physical status I - III
Elective non-cardiac surgical procedures under general anesthesia
Disqualifiers
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
Trial population
Patients greater then 65 years age undergoing elective non-cardiac surgical procedures under general anesthesia
Trial design
Cohort
Prospective
Treatments tested in this trial
Sevoflurane
DrugSevoflurane delivery will will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
Desflurane
DrugDesflurane delivery will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
Treatment groups
Trial outcomes
Primary outcomes
Incidence of postoperative delirium
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
Secondary outcomes
Postoperative Sedation
Postoperative sedation will be assessed using the 10 point Richmond Agitation and Sedation Scale. +4 suggests overtly combative \& violent, 0 suggests awake \& quiet, and -5 suggets no response to voice or physical stimulation
Postoperative Pain
It will be assessed using the 10-point Numeric Rating Scale (NRS). A score of 0 suggests 'no pain'and score of 10 suggests 'maximum pain'experienced
Postoperative nausea and vomiting
It will be assessed using 3-point likert scale. A score of 0 suggests 'no nausea \& vomiting'and a scoe of 2 suggests 'nausea \& vomiting present'
Length of hospital stay
The number of days the patient stays in the hospital post surgery till discharge will be recorded.
Other outcomes
Correlation of risk factors with postoperative delirium
Correlation between age more than 75 years, frailty, cognitive dysfunction, impaired physical mobility, comorbidity and polypharmacy with postoperative delirium will be assessed using multivariate or univariate analysis as applicable
Sponsors and contacts
Click on the lead sponsor to view all of their trials.