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The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery

NCT ID: NCT06349057

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-30

Brief Summary

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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

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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

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Postoperative Recovery Length of Hospital Stay Postoperative Complications

Keywords

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cardiac surgery anticholinergic burden elderly represcribing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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)

Group Type ACTIVE_COMPARATOR

reducing anticholinergic burden

Intervention Type DRUG

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

Interventions

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reducing anticholinergic burden

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

Intervention Type DRUG

Other Intervention Names

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not reducing anticholinergic burden, routine care

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Muhammed Çobas

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aslıhan Aykut, specialist

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

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Aslihan Aykut

Ankara, çankaya, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Aslıhan Aykut, specialist

Role: CONTACT

Phone: +905325502013

Email: [email protected]

muhammed çobas, specialist

Role: CONTACT

Phone: +95542693986

Email: [email protected]

Facility Contacts

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aslihan aykut, specialist

Role: primary

zeliha asli demir, profesor

Role: backup

References

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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.

Reference Type RESULT
PMID: 32979483 (View on PubMed)

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.

Reference Type RESULT
PMID: 25597560 (View on PubMed)

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.

Reference Type RESULT
PMID: 27349795 (View on PubMed)

Other Identifiers

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AnkaraCHBilkent.1

Identifier Type: -

Identifier Source: org_study_id