The Relationship Between Anticholinergic Burden and Postoperative Complications After Cardiac Surgery in Older Adults

Postoperative Complications Clinical Trial

Official title:

The Relationship Between Anticholinergic Burden and Postoperative Complications After Cardiac Surgery in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05312684
• Other study ID #: 22-2476
• Status: Not yet recruiting
• Start date: April 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2022
• Source: Gulhane Training and Research Hospital
• Contact: Bilal Katipoglu, MD
• Phone: +905543330380
• Email: drbilal07[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Drugs with anticholinergic properties are widely prescribed in the elderly population, despite increasing evidence in the literature regarding side effects and adverse outcomes. As is known, many drugs have anticholinergic activity, which means that they block the binding of the neurotransmitter acetylcholine to the muscarinic receptor. In this case, the occurrence of anticholinergic side effects becomes inevitable. Central effects such as cognitive impairment, dizziness, sedation, confusion or delirium, and peripheral effects such as dry mouth, dry eyes, constipation, urinary retention, and tachycardia begin to be seen in patients. Anticholinergic load refers to the cumulative effect of taking one or more drugs with anticholinergic activity. This cumulative effect is a strong indicator of cognitive and physical deterioration, especially in the elderly population. It is also associated with adverse outcomes such as falls, impaired functioning, and higher rates of hospitalization and death. Anticholinergic load scales include scales that facilitate the work of physicians used in clinical practice to predict anticholinergic side effects in humans. Although there are many different scales used at this point, one of the scales with the highest validity and reliability in recent studies are Anticholinergic cognitive burden scale (ACB) and Anticholinergic risk scale (ARS). To the best of our knowledge, we could not find any study on postoperative complications, length of hospital stay and mortality after cardiac surgery with these scales. Therefore, we aimed to examine the relationship between possible complications after cardiac surgery and anticholinergic load scales showing the cumulative effect of preoperative drugs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 100 Years

Eligibility

Inclusion Criteria:

• It is planned to include patients over the age of 65 who underwent cardiac surgery in the research population.
• Gender discrimination will not be considered.

Exclusion Criteria:

• Those who are under the age of 65,
• Those who have non-cardiac surgery,
• Those whose drug records cannot be accessed

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• cardiac surgery
cardiovascular surgery including valve repair/replacement or CABG or combined procedures

Locations

Country	Name	City	State
Turkey	Gulhane training and research hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complication	Dindo classification	1 month fellow-up