Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2026-03-31 @ 10:52 AM
Study NCT ID:
NCT06349057
Status:
RECRUITING
Last Update Posted:
2025-12-22
First Post:
2024-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery
Sponsor:
Ankara City Hospital Bilkent
Organization:
Study Overview
Official Title:
Anticholinergic Burden as a Modifiable Risk Factor in Cardiac Surgery: Evidence From a Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: