Postoperative RecoveryPhase 4NCT06349057
The Effect of the Anticholinergic Burden Following Elective Coronary Artery Surgery
A Phase 4 study testing reducing anticholinergic burden in people with Postoperative Recovery and Length of Hospital Stay, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Recovery, Length of Hospital Stay, Postoperative Complications
- What is being tested?
- reducing anticholinergic burden
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective coronary artery bypass surgery
- Patients with high anticholinergic burden
Who cannot join
- All other procedures except isolated coronary bypass surgery
- Patients with low anticholinergic burden
- Patients whose records cannot be accessed through the data system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- reducing anticholinergic burden
- Keywords
- cardiac surgery, anticholinergic burden, elderly, represcribing
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reducing anticholinergic burdenDrug
Also called not reducing anticholinergic burden, routine care
In the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: reducing anticholinergic burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 90
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: From completion of surgery to postoperative day 90
all-cause mortality
All-cause mortality occurring within 90 days after surgery.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline (preoperative) to postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start1 Jan 2024
- Primary completion1 Oct 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative RecoveryStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Çobas, Ankara City Hospital Bilkent
- Investigators
- Aslıhan Aykut, specialist, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349057
- Sponsor's protocol ID
- AnkaraCHBilkent.1
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32979483Salahudeen 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.
PubMed 25597560Magin 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.
PubMed 27349795
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticholinergic Burden as a Modifiable Risk Factor in Cardiac Surgery: Evidence From a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06349057
- Acronym / sponsor ID
- AnkaraCHBilkent.1
- Keywords
- cardiac surgery, anticholinergic burden, elderly, represcribing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 5 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: reducing anticholinergic burdenPreoperative 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) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing elective coronary artery bypass surgery
- Patients with high anticholinergic burden
Key exclusion criteria (3 listed)
- All other procedures except isolated coronary bypass surgery
- Patients with low anticholinergic burden
- Patients whose records cannot be accessed through the data system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| reducing anticholinergic burdenAlso: not reducing anticholinergic burden, routine careIn the intraoperative and postoperative periods instead of drugs with high anticholinergic burden; drugs with low burden will be preferred. | Drug | Remifentanyl, Propofol, Sevoflurane / Desflurane, Propofol |
Primary outcome
Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS)
Time frame: Postoperative day 90
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.
9 secondary outcomes
Intensive Care Unit Length of Stay (days)
Time frame: From postoperative ICU admission until ICU discharge (typically within 1-3 days).
Duration of Mechanical Ventilation (hours)
Time frame: From the end of surgery to extubation
other postoperative complications
Time frame: From completion of surgery to postoperative day 90
all-cause mortality
Time frame: From completion of surgery to postoperative day 90
Change in Katz Index of Independence in Activities of Daily Living From Baseline
Time frame: Baseline (preoperative) to postoperative day 90
Postoperative major cardiac complications
Time frame: From completion of surgery to postoperative day 90
Hospital length of stay (days)
Time frame: From hospital admission for surgery until hospital discharge (typically within 5-10 days).
Incidence of major pulmonary complications
Time frame: From completion of surgery to postoperative day 90
Change in Clinical Frailty Scale (CFS) from baseline
Time frame: Baseline (preoperative) to postoperative day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Results publication: PubMed 32979483Hebert 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.
- Results publication: PubMed 25597560Salahudeen 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.
- Results publication: PubMed 27349795Magin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslıhan Aykut, specialist principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing reducing anticholinergic burden in people with Postoperative Recovery and Length of Hospital Stay, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS) (time frame: Postoperative day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06349057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.