The impact of rivastigmine on post‐surgical delirium and cognitive impairment; a randomized clinical trial

• Published in: International journal of geriatric psychiatry 2023-07, Vol.38 (7), p.e5970-n/a
• Main Authors: Massoudi, Nilofar, Mohit, Babak, Fathi, Mohammad, Nooraei, Navid, Hannani, Kia Kazemzadeh, ArianNik, Mohsen
• Format: Article
• Language: English
• Subjects: anesthesia; cholinesterase inhibitor; Cholinesterase inhibitors; Cholinesterase Inhibitors - adverse effects; Clinical trials; Cognitive ability; cognitive dysfunction; Cognitive Dysfunction - drug therapy; Cognitive Dysfunction - etiology; Delirium; Delirium - drug therapy; Delirium - etiology; Double-blind studies; Geriatric psychiatry; Humans; Patients; Pediatrics; Phenylcarbamates - adverse effects; postoperative period; Regression analysis; Rivastigmine; Rivastigmine - therapeutic use; Surgery
• ISSN: 0885-6230; 1099-1166
• DOI: 10.1002/gps.5970

Background Delirium is an acute and transient disorder of brain function that often occurs in post‐surgical patients. Rivastigmine is a cholinesterase inhibitor drug that has been proposed as an adjuvant drug in recent years, still, despite significant theoretical evidence, few clinical studies have been performed on its impact on delirium. Aim Due to the widespread use of cholinesterase inhibitors in pediatric and adult surgery, the present study aims to investigate the impact of Rivastigmine as a cholinesterase inhibitor on delirium after radical surgery. Methods In this randomized double‐blind clinical trial, a hundred recruited patients were randomly assigned to either Rivastigmine (n = 50) or placebo (n = 50) groups, and we measured post‐operative impact on delirium, by Confusion Assessment Method (CAM) score, and cognitive impairment, by the Mini‐Mental State Examination (MMSE). Our univariate and multivariate logistical regression models assessed this hypothesized impact. Results Treatment with Rivastigmine was significantly associated with reduced day one post‐op delirium, as measured by CAM score (Odds Ratio (OR) = 0.35, 95% Confidence Interval (CI) 0.11 to 0.97, p = 0.05), and cognitive impairment, as measured by MMSE (OR = 0.25, 95% CI 0.1 to 0.59, p = 0.0022). These associations became stronger after controlling for age, blood loss, and post‐op blood sodium levels: Delirium (OR = 0.23, 95% CI 0.05 to 0.92, p = 0.05), cognitive impairment (OR = 0.12, 95% CI 0.03 to 0.42, p = 0.000178). Conclusion The significant result of our randomized clinical trial is that pre‐op Rivastigmine treatment may be associated with a substantial drop in patients experiencing post‐op delirium and post‐op cognitive impairment. Key points Delirium is an acute and transient disorder of brain function that often occurs in post‐surgical patients. Rivastigmine is a cholinesterase inhibitor drug that has been proposed as an adjuvant drug in recent years, still, despite significant theoretical evidence, few clinical studies have been performed on its impact on delirium. In this randomized double‐blind clinical trial, a hundred recruited patients were randomly assigned to either Rivastigmine (n = 50) or placebo (n = 50) groups. The Confusion Assessment Method (CAM) was used to assess delirium as a binomial variable. Mini‐Mental State Examination (MMSE) instruments were also used to assess the patient's cognitive status, performed on the first day after surgery. Treatment with