Clinical Trials Directory

Trials / Completed

CompletedNCT06349057

The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery

Anticholinergic Burden as a Modifiable Risk Factor in Cardiac Surgery: Evidence From a Randomized Controlled Study

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Ankara City Hospital Bilkent · Academic / Other
Sex
All
Age
60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGreducing anticholinergic burdenIn the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.

Timeline

Start date
2024-01-01
Primary completion
2025-10-01
Completion
2025-12-30
First posted
2024-04-05
Last updated
2026-02-24

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06349057. Inclusion in this directory is not an endorsement.