The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery

The Effect of the Anticholinergic Burden on Complications and Mortality Following Elective Coronary Artery Surgery in Patients Over 60 Years

Many drugs have anticholinergic activity. This means that it blocks the muscarinic binding of the neurotransmitter acetylcholine.

In this study, the anticholinergic burden of the patients in the perioperative period will be calculated with the Anticholinergic Cognitive Burden Scale (ACBS) and patients with a score of 1 or above will be included in the study. Anticholinergic load of drugs used in the intraoperative period; Its effect on postoperative hospital stay, morbidity and mortality following elective heart surgery will be investigated.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Mortality
• Intervention / Treatment: Drug: reducing anticholinergic burden

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Seda Kurtbeyoğlu, DOCTOR; Phone Number: +905388342776; Email: kurtbeyogluseda@gmail.com
• Study Contact Backup: Name: muhammed çobas, DOCTOR; Phone Number: +95542693986; Email: mcobas7633@gmail.com

Study Locations

• Turkey
  • Ankara
    • Çankaya, Ankara, Turkey, 06800
      • Recruiting
      • Seda Kurtbeyoğlu
      • Contact: Seda Kurtbeyoğlu; Phone Number: +905388342776; Email: kurtbeyogluseda@gmail.com

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: Treatment
• 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 - Talinat®, Tramadol- Contamal®, Midazolam - Dormicum®, Pancuronium-Mivacron®) Lower burden drugs : (Remifentanyl-Ultiva®, Sevoflurane-Sevoflurane USP® , Desflurane-Suprane®, Propofol-Propofol®, Rocuronium-Esmeron®, Lidocaine-Aritmal®)	Drug: reducing anticholinergic burden; In the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The patient will be visited every day during his/her stay in the hospital, and then the patient will be contacted by phone on the 90th day.Patient information will be checked from the hospital database.	Postoperative 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects on postoperative recovery	Daily living and the recovery processes of the patients in both preoperative and the postoperative period will be recorded using The Katz Activities of Daily Living Scale it measures six activities : continence, bathing, dressing, toileting, transferring (from one surface to another), and feeding. Each activity is graded on a scale of 0 (dependence) to 1 (independence). Calculates total score. 0-2: dependent 3-4: partially dependent 5-6:independent	preoperative and postoperative 90 days
Effects on postoperative recovery	Fraility and the recovery processes of the patients in both preoperative and the postoperative period will be recorded using The Clinical Frailty Scale (which is a nine-point scale based on clinical evaluation of mobility, energy, physical activity, and function. 1-Very Fit 2 -Well 3-Managing Well 4 -Vulnerable 5 -Mildly Frail 6-Moderately Frail 7-Severely Frail 8-Very Severely Frail 9-Terminally Ill	Postoperative 90 days
Postoperative complication	It will be monitored whether complications develop and reported if tehy occur, within 90 days.; Cardiac arrest,; Cardiac reoperation for bleeding; Cardiac reoperation other than bleeding; Deep sternal wound infection; Stroke (ischemic/hemorrhagic); Pneumonia / Pulmonary edema / Pleural effusion; Infection (urinary infection,wound infection, catheter infection, meningitis, mediastinitis, sepsis); Acute renal failure (to be assessed by the KDIGO criteria; increase in sCr ≥0.3 mg/dL (≥26.5 μmol/L) within 48 hours; or increase in sCr ≥1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or 3 Urine volume <0.5 mL/kg/h for 6 hours) The patient will be visited every day during his/her stay in the hospital, and then the patient will be contacted by phone on the 90th day. Patient information will be checked from the hospital database.	Postoperative 90 days

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: Seda Kurtbeyoğlu, DOCTOR, 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. Erratum In: J Clin Pharm Ther. 2016 Dec;41(6):741.

Study record dates

Study Major Dates

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

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): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; anticholinergic burden
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; 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