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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications; Postoperative Recovery; Length of Hospital Stay
• Intervention / Treatment: Drug: reducing anticholinergic burden

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • çankaya
    • Ankara, çankaya, Turkey (Türkiye), 06800
      • Aslihan Aykut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care; There will be no intervention in the perioperative period, data will be collected only by observation. Anesthesia management, surgical procedure and postoperative care will be applied as routine.
Active Comparator: Remifentanyl, Propofol, Sevoflurane / Desflurane, Propofol; Preoperative period : There will be no intervention. Intraoperative period : An erector spinae plane block will be applied before anesthesia induction. Drugs with cholinergic burden will not be preferred. Lower anticholinergic drugs will be used. There will be no intervention in the surgical procedure. Postoperative period : Drugs with high cholinergic burden will not be used. Lower anticholinergic drugs will be used. Intraoperative and postoperative periods, instead of drugs with high anticholinergic burden; lower burden drugs will be preferred. High anticholinergic burden drugs: (Fentanyl -, Tramadol-, Midazolam , Pancuronium9 Lower burden drugs : (Remifentanyl, Sevoflurane, Desflurane, Propofol, Rocuronium, Lidocaine)	Drug: reducing anticholinergic burden; In the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.; Other Names: not reducing anticholinergic burden, routine care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS)	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.	Postoperative day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive Care Unit Length of Stay (days)	The duration of stay in the intensive care unit, measured in days, from ICU admission after surgery until ICU discharge.	From postoperative ICU admission until ICU discharge (typically within 1-3 days).
Duration of Mechanical Ventilation (hours)	The duration of postoperative mechanical ventilation, measured in hours, from end of surgery until successful extubation.	From the end of surgery to extubation
other postoperative complications	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.	From completion of surgery to postoperative day 90
all-cause mortality	All-cause mortality occurring within 90 days after surgery.	From completion of surgery to postoperative day 90
Change in Katz Index of Independence in Activities of Daily Living From Baseline	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.	Baseline (preoperative) to postoperative day 90
Postoperative major cardiac complications	Incidence of major postoperative cardiac complications, including cardiac arrest, myocardial infarction, arrhythmia, and aortic dissection.	From completion of surgery to postoperative day 90
Hospital length of stay (days)	Duration of postoperative hospital stay, measured in days, from admission to the hospital after surgery until hospital discharge.	From hospital admission for surgery until hospital discharge (typically within 5-10 days).
Incidence of major pulmonary complications	Major postoperative pulmonary complications, including pneumothorax, pleural effusion, pulmonary embolism, and acute respiratory distress syndrome (ARDS).	From completion of surgery to postoperative day 90
Change in Clinical Frailty Scale (CFS) from baseline	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: = Very Fit; = Well; = Managing Well; = Vulnerable; = Mildly Frail; = Moderately Frail; = Severely Frail; = Very Severely Frail; = Terminally Ill Higher scores indicate greater frailty.	Baseline (preoperative) to postoperative day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in hospital and intensive care unit	we will record days	Postoperative 90 days

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Aslıhan Aykut, specialist, Ankara City Hospital Bilkent

Publications and helpful links

General Publications

• Hebert M, Cartier R, Dagenais F, Langlois Y, Coutu M, Noiseux N, El-Hamamsy I, Stevens LM. Standardizing Postoperative Complications-Validating the Clavien-Dindo Complications Classification in Cardiac Surgery. Semin Thorac Cardiovasc Surg. 2021 Summer;33(2):443-451. doi: 10.1053/j.semtcvs.2020.09.029. Epub 2020 Sep 24.
• Salahudeen MS, Hilmer SN, Nishtala PS. Comparison of anticholinergic risk scales and associations with adverse health outcomes in older people. J Am Geriatr Soc. 2015 Jan;63(1):85-90. doi: 10.1111/jgs.13206.
• Magin PJ, Morgan S, Tapley A, McCowan C, Parkinson L, Henderson KM, Muth C, Hammer MS, Pond D, Mate KE, Spike NA, McArthur LA, van Driel ML. Anticholinergic medicines in an older primary care population: a cross-sectional analysis of medicines' levels of anticholinergic activity and clinical indications. J Clin Pharm Ther. 2016 Oct;41(5):486-92. doi: 10.1111/jcpt.12413. Epub 2016 Jun 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): December 30, 2025

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: cardiac surgery; elderly; anticholinergic burden; represcribing
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Cholinergic Agents; Cholinergic Antagonists
• Other Study ID Numbers: AnkaraCHBilkent.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No