Understanding postoperative delirium in elderly patients after non-cardiac surgery
The Incidence, Risk Factors and Outcome of Postoperative Delirium in Elderly Patients Undergoing Non-cardiac Surgery: a Prospective Observational Study
This study looks at how common confusion after surgery is in older patients over 65 who are having non-heart surgeries to see what might cause it and how to help prevent it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Sir Ganga Ram Hospital Academic / other |
| Locations | 2 sites (New Delhi, National Capital Territory of Delhi and 1 other locations) |
| Trial ID | NCT04707794 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the incidence of postoperative delirium (POD) in elderly patients aged over 65 undergoing elective non-cardiac surgeries. It will involve 150 patients classified as ASA Physical Status I-III and will utilize the validated 4 A's test for rapid assessment of delirium. The study will explore various predisposing and precipitating factors contributing to POD, with a focus on improving patient outcomes and reducing healthcare costs associated with this complication. The findings could help in identifying at-risk patients and implementing preventive strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly patients over 65 years old undergoing elective non-cardiac surgeries who are in ASA Physical Status I-III.
Not a fit: Patients with severe psychiatric or neurological diseases, recent surgeries, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and prevention of postoperative delirium in elderly patients, enhancing their recovery and reducing hospital stays.
How similar studies have performed: Previous studies have indicated varying success in identifying and managing postoperative delirium, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
New Delhi, National Capital Territory of Delhi and 1 other locations
- Sir Ganga Ram Hospital — New Delhi, National Capital Territory of Delhi, India (Recruiting)
- Sir Ganga Ram Hospital — New Delhi, India (Not_yet_recruiting)
Study contacts
- Principal investigator: Nitin Sethi, MBBS, DNB — Sir Ganga Ram Hospital
- Study coordinator: Bimla Sharma, MBBS, DGO, MD, FICA, MHA
- Email: bimsharma1@gmail.com
- Phone: 00911142252523
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.