Length of Hospital Stay, Postoperative Complications, Postoperative Recovery
Conditions
Keywords
cardiac surgery, anticholinergic burden, elderly, represcribing
Brief summary
Anticholinergic drugs are common in older adults and linked to cognitive decline, frailty, longer hospital stay, and higher mortality. This cumulative burden, often increased by anesthetics and analgesics, may worsen during surgery. The study evaluates whether reducing perioperative anticholinergic load improves recovery after cardiac surgery.
Detailed description
Anticholinergic agents are frequently prescribed in older adults and have been linked to negative outcomes such as cognitive decline, frailty, extended hospitalization, and increased mortality. The cumulative exposure, referred to as anticholinergic burden, may be exacerbated during the perioperative period due to anesthetic and analgesic use. This trial explores whether minimizing perioperative anticholinergic burden can improve postoperative recovery following cardiac surgery. In this prospective, randomized controlled study, 120 patients aged 60 years or older undergoing isolated coronary artery bypass grafting with a preoperative Anticholinergic Cognitive Burden score of ≥3 were included. Participants were assigned either to standard perioperative care involving anesthetic and analgesic agents with anticholinergic activity (Group Standard) or to a deprescribing protocol excluding all anticholinergic drugs intraoperatively and postoperatively (Group Deprescribing). The primary endpoints were functional recovery assessed at 90 days using the Katz Index and Clinical Frailty Scale. Secondary endpoints comprised hospital length of stay, 90-day incidence of cardiac and pulmonary complications, intensive care Unit stay, duration of mechanical ventilation, additional complications, and 90-day mortality. The Wilcoxon signed-rank test was used for paired comparisons of Katz and frailty scores, while multivariate logistic regression was applied to identify independent predictors of postoperative cardiac complications.
Interventions
DRUGreducing anticholinergic burden
In the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.
Sponsors
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing elective coronary artery bypass surgery * Patients with high anticholinergic burden
Exclusion criteria
* All other procedures except isolated coronary bypass surgery * Patients with low anticholinergic burden * Patients whose records cannot be accessed through the data system
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS) | Postoperative day 90 | The Katz Index of Independence in Activities of Daily Living evaluates a patient's ability to perform six basic functions: bathing, dressing, toileting, transferring, continence, and feeding. Each activity is scored as either "independent" (1 point) or "dependent" (0 points). The total score reflects the patient's overall level of functional independence. The Clinical Frailty Scale (CFS) is a validated 9-point tool used to assess a patient's baseline frailty status. It evaluates physical fitness, comorbidity burden, functional dependence, and overall health status. Scores range from 1 (Very Fit) to 9 (Terminally Ill). Higher scores indicate greater frailty and worse baseline physiological reserve. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensive Care Unit Length of Stay (days) | From postoperative ICU admission until ICU discharge (typically within 1-3 days). | The duration of stay in the intensive care unit, measured in days, from ICU admission after surgery until ICU discharge. |
| Duration of Mechanical Ventilation (hours) | From the end of surgery to extubation | The duration of postoperative mechanical ventilation, measured in hours, from end of surgery until successful extubation. |
| other postoperative complications | From completion of surgery to postoperative day 90 | Occurrence of postoperative complications within 90 days after surgery, including neurological (stroke, transient ischemic attack, seizures), renal (acute kidney injury, need for renal replacement therapy, chronic renal failure), and infectious complications (pneumonia, mediastinitis, meningitis, urinary tract infection, wound infection, catheter-related sepsis), as well as delirium. |
| all-cause mortality | From completion of surgery to postoperative day 90 | All-cause mortality occurring within 90 days after surgery. |
| Change in Katz Index of Independence in Activities of Daily Living From Baseline | Baseline (preoperative) to postoperative day 90 | The change in Katz Index score will be calculated as the postoperative day 90 score minus the preoperative baseline score. The Katz Index ranges from 0 (highly dependent) to 6 (independent). Higher scores indicate better functional independence. |
| Postoperative major cardiac complications | From completion of surgery to postoperative day 90 | Incidence of major postoperative cardiac complications, including cardiac arrest, myocardial infarction, arrhythmia, and aortic dissection. |
| Hospital length of stay (days) | From hospital admission for surgery until hospital discharge (typically within 5-10 days). | Duration of postoperative hospital stay, measured in days, from admission to the hospital after surgery until hospital discharge. |
| Incidence of major pulmonary complications | From completion of surgery to postoperative day 90 | Major postoperative pulmonary complications, including pneumothorax, pleural effusion, pulmonary embolism, and acute respiratory distress syndrome (ARDS). |
| Change in Clinical Frailty Scale (CFS) from baseline | Baseline (preoperative) to postoperative day 90 | Change in Clinical Frailty Scale (CFS) score from preoperative baseline to postoperative day 90. The CFS is a nine-point scale assessing mobility, energy, physical activity, and overall functional health: 1. = Very Fit 2. = Well 3. = Managing Well 4. = Vulnerable 5. = Mildly Frail 6. = Moderately Frail 7. = Severely Frail 8. = Very Severely Frail 9. = Terminally Ill Higher scores indicate greater frailty. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORAslıhan Aykut, specialist
Ankara City Hospital Bilkent
Outcome results
None listed