Efficiency of Donepezil in Elderly Patients Undergoing Orthopaedic Surgery Due To Underlying Post-Operative cognitive Dysfunction: Study Protocol for A Multicentre Randomised Controlled Trial

2021 ◽  
Author(s):  
Huichen Zhu ◽  
Lu Cong ◽  
Yi Chen ◽  
Shaoyi Chen ◽  
Lingke Chen ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Elderly Patients ◽  
Cognitive Dysfunction ◽  
Orthopaedic Surgery ◽  
Controlled Trial ◽  
Acetylcholinesterase Inhibitor ◽  
Critical Role ◽  
Double Blind ◽  
Choline Acetyl Transferase ◽  
Randomised Controlled

Abstract Background Post-operative cognitive dysfunction (POCD) is an overarching term used to describe cognitive impairment identified in the preoperative or post-operative period. After surgical operations, older patients are particularly vulnerable to memory disturbances and other types of cognitive impairment. However, the pathogenesis of POCD remains unclear and no confirmed preventable or treatment strategy avilable. Our previous study demonstrated that the concentration of choline acetyl transferase in the cerebral spinal fliud was a predictive factor of POCD, and donepezil is an acetylcholinesterase inhibitor which was used in clinical for the treatment of alzheimer's disease can prevent the learning and memory impairment after anesthesia/surgery in aged mice. This study aimed to determine the critical role of donepezil in preventing cognitive impairment in elder patients undergoing orthopaedic surgery. Methods A multicentre, double-blind, placebo-controlled, crossover clinical trial will be performed to assess the efficacy of donepezil in elderly patients undergoing orthopaedic surgery. Participants (n = 360) will receive donepezil (5 mg once daily) or placebo from 1 day prior to surgery until 5 days after surgery. Neuropsychological tests will be measured at 1 day before the operation and 1 week, 1 month, 6 months and 1 year after the operation. Discussion This research project mainly aimed to study the effects of donepezil in elderly patients undergoing orthopaedic surgery due to underlying POCD and to investigate the underlying physiological and neurobiological mechanisms of these effects. The results may provide important implications for the development of effective interfering strategies, specifically regarding cognitive dysfunction therapy using drugs. Trial registration: ClinicalTrials.gov, NCT04423276. Registered on 14 June 2020.

scholarly journals Efficiency of donepezil in elderly patients undergoing orthopaedic surgery due to underlying post-operative cognitive dysfunction: study protocol for a multicentre randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Huichen Zhu ◽  
Lu Cong ◽  
Yi Chen ◽  
Shaoyi Chen ◽  
Lingke Chen ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Elderly Patients ◽  
Cognitive Dysfunction ◽  
Orthopaedic Surgery ◽  
Controlled Trial ◽  
Acetylcholinesterase Inhibitor ◽  
Critical Role ◽  
Double Blind ◽  
Choline Acetyl Transferase ◽  
Link Type

Abstract Background Post-operative cognitive dysfunction (POCD) is an overarching term used to describe cognitive impairment identified in the preoperative or post-operative period. After surgical operations, older patients are particularly vulnerable to memory disturbances and other types of cognitive impairment. However, the pathogenesis of POCD remains unclear with no confirmed preventable or treatable strategy available. Our previous study demonstrated that the concentration of choline acetyl transferase in the cerebral spinal fluid was a predictive factor of POCD and that donepezil, which is an acetylcholinesterase inhibitor used in clinical settings for the treatment of Alzheimer’s disease, can prevent learning and memory impairment after anaesthesia/surgery in aged mice. This study aimed to determine the critical role of donepezil in preventing cognitive impairment in elderly patients undergoing orthopaedic surgery. Methods A multicentre, double-blind, placebo-controlled, crossover clinical trial will be performed to assess the efficacy of donepezil in elderly patients undergoing orthopaedic surgery. Participants (n = 360) will receive donepezil (5 mg once daily) or placebo from 1 day prior to surgery until 5 days after surgery. Neuropsychological tests will be measured at 1 day before the operation and 1 week, 1 month, 6 months and 1 year after the operation. Discussion This research project mainly aimed to study the effects of donepezil in elderly patients undergoing orthopaedic surgery due to underlying POCD and to investigate the underlying physiological and neurobiological mechanisms of these effects. The results may provide important implications for the development of effective interfering strategies, specifically regarding cognitive dysfunction therapy using drugs. Trial registration ClinicalTrials.govNCT04423276. Registered on 14 June 2020

scholarly journals Efficacy of Donepezil in Improving Cognitive Impairment Induced by Electroconvulsive Therapy in Patients with Mood Disorders: A Randomized, Double-blind, Placebo-Controlled Trial

2021 ◽  
Vol 15 (3) ◽  
Author(s):  
Elham Zarean ◽  
Morteza Sedehi ◽  
Yalda Heshmati
Keyword(s):  
Cognitive Impairment ◽  
Mood Disorder ◽  
Mood Disorders ◽  
Electroconvulsive Therapy ◽  
Controlled Trial ◽  
Acetylcholinesterase Inhibitor ◽  
Double Blind ◽  
Mini Mental Status Examination ◽  
Cognitive Disturbances ◽  
Addenbrooke’S Cognitive Examination

Background: Electroconvulsive therapy (ECT) is an effective strategy in the treatment of mood disorders; however, it is associated with some cognitive complications. Objectives: This study aimed to evaluate the efficacy of donepezil as an acetylcholinesterase inhibitor in improving cognitive impairment induced by ECT in mood disorder patients. Methods: Ninety-six mood disorder patients were randomly assigned to the donepezil (5mg/day) or placebo groups. The Persian versions of the Mini-Mental Status examination (MMSE) and Addenbrooke’s Cognitive Examination Revised (ACE-R) were used to evaluate cognitive performance before the first ECT session, after the fourth ECT session, and four weeks after the last ECT session. Results: The mean scores of MMSE and ACE-R revealed significant improvement in the donepezil group over time (P < 0.001). All ACE-R subscales increased significantly following the intervention implementation in the donepezil group (P < 0.001). Furthermore, the donepezil group reported no remarkable complications and completed the study. Conclusions: Donepezil co-administration with ECT may improve the ECT-induced cognitive disturbances.

Follow-up telephone calls to patients discharged after undergoing orthopaedic surgery: double-blind, randomised controlled trial of efficacy

2015 ◽  
Vol 24 (19-20) ◽  
pp. 2736-2744 ◽  
Author(s):  
Marco Clari ◽  
Simona Frigerio ◽  
Fulvio Ricceri ◽  
Andrea Pici ◽  
Rosaria Alvaro ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Orthopaedic Surgery ◽  
Controlled Trial ◽  
Double Blind ◽  
Telephone Calls ◽  
Randomised Controlled

scholarly journals Impact of multimodal warming during general anaesthesia on postoperative cognitive dysfunction in elderly patients with gynaecological cancer: study protocol for a single-blinded randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e049186
Author(s):  
Jinxi Zhang ◽  
Shixiong Song ◽  
Qing Zhu
Keyword(s):  
Randomised Controlled Trial ◽  
Elderly Patients ◽  
Cognitive Dysfunction ◽  
Controlled Trial ◽  
Postoperative Cognitive Dysfunction ◽  
Cancer Surgery ◽  
Gynaecological Cancer ◽  
Reliable Change Index ◽  
Resource Utilisation ◽  
Randomised Controlled

BackgroundCognitive impairment after anaesthesia and surgery is a recognised consequence. This often leads to poor health outcomes and increases healthcare resource utilisation and associated costs, especially in elderly people. However, thus far, there have not been any effective therapies for managing postoperative cognitive dysfunction (POCD). Furthermore, research on the association of multimodal warming with POCD and the clinical outcomes in older patients after gynaecological surgery has not been rigorous. For these reasons, our investigation aims to evaluate whether perioperative multimodal warming would reduce the incidence of POCD and improve prognosis in elderly patients with gynaecological cancer.Methods and analysisThis is a single-centre, prospective, single-blinded randomised controlled trial. One hundred and fifty patients for gynaecological cancer surgery and 16 non-surgical controls aged 65 years or older will be studied in this trial. A series of neuropsychological tests will be completed to evaluate cognitive function in surgery patients before, at day 7 and 3 months after gynaecological cancer surgery. In addition, POCD and cognitive decline will be assessed using the reliable change index using the control group’s results. The primary outcome is the prevalence of POCD in elderly gynaecological cancer surgery patients and association between perioperative multimodal warming and POCD.Ethics and disseminationThe protocol for this prospective observational study was approved by the ethics committee of the West China Second University Hospital, Sichuan University (NO. KX215). Recruitment will commence in April 2021 and continue to April 2022. The findings of this trial will be disseminated in peer-reviewed journals and scientific meetings.Trial registration numberChiCTR2100041663.

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