Anticholinergic Burden as a Modifiable Risk Factor in Cardiac Surgery: Evidence From a Randomized Controlled Study
概览
- 阶段
- 4 期
- 干预措施
- reducing anticholinergic burden
- 疾病 / 适应症
- 未指定
- 发起方
- Ankara City Hospital Bilkent
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Muhammed Çobas
Principal Investigator
Ankara City Hospital Bilkent
入排标准
入选标准
- •Patients undergoing elective coronary artery bypass surgery
- •Patients with high anticholinergic burden
排除标准
- •All other procedures except isolated coronary bypass surgery
- •Patients with low anticholinergic burden
- •Patients whose records cannot be accessed through the data system
研究组 & 干预措施
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)
干预措施: reducing anticholinergic burden
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.
结局指标
主要结局
Katz Index of Independence in Activities of Daily Living and Clinical Frailty Scale (CFS)
时间窗: 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.
次要结局
- 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)
- Postoperative major cardiac complications(From completion of surgery to postoperative day 90)
- Hospital length of stay (days)(From hospital admission for surgery until hospital discharge (typically within 5-10 days).)
- Incidence of major pulmonary complications(From completion of surgery to postoperative day 90)
- Change in Clinical Frailty Scale (CFS) from baseline(Baseline (preoperative) to postoperative day 90)