The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery

NCT06349057 | Completed Phase 4

• 1 other identifier: AnkaraCHBilkent.1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Length of Hospital Stay; Postoperative Complications; Postoperative Recovery

Keywords

cardiac surgery; anticholinergic burden; elderly; represcribing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Intensive Care Unit Length of Stay (days)

  From postoperative ICU admission until ICU discharge (typically within 1-3 days).

• Duration of Mechanical Ventilation (hours)

  From the end of surgery to extubation

• other postoperative complications

  From completion of surgery to postoperative day 90

• all-cause mortality

  From completion of surgery to postoperative day 90

• Change in Katz Index of Independence in Activities of Daily Living From Baseline

  Baseline (preoperative) to postoperative day 90

Study Arms (2)

Standard of care

NO INTERVENTION

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.

Remifentanyl, Propofol, Sevoflurane / Desflurane, Propofol

ACTIVE COMPARATOR

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

Interventions

reducing anticholinergic burden DRUG

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

Also known as: not reducing anticholinergic burden, routine care

Remifentanyl, Propofol, Sevoflurane / Desflurane, Propofol

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective coronary artery bypass surgery
• Patients with high anticholinergic burden

You may not qualify if:

• All other procedures except isolated coronary bypass surgery
• Patients with low anticholinergic burden
• Patients whose records cannot be accessed through the data system

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Aslihan Aykut

Ankara, çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32979483 RESULT

• 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.

  PMID: 25597560 RESULT

• 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.

  PMID: 27349795 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aslıhan Aykut, specialist

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 5, 2024
• Study Start: January 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 30, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)