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.

scholarly journals Impact of inhalational versus intravenous anaesthesia on early delirium and long-term survival in elderly patients after cancer surgery: study protocol of a multicentre, open-label, and randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e018607 ◽  
Author(s):  
Yue Zhang ◽  
Hui-Juan Li ◽  
Dong-Xin Wang ◽  
Hui-Qun Jia ◽  
Xu-De Sun ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Elderly Patients ◽  
Controlled Trial ◽  
Cancer Surgery ◽  
Term Survival ◽  
Intravenous Anaesthesia ◽  
Long Term Survival ◽  
Inhalational Anaesthesia ◽  
Randomised Controlled

IntroductionElderly patients who have solid organ cancer often receive surgery. Some of them may develop delirium after surgery and delirium development is associated with worse outcomes. Furthermore, despite all of the advances in medical care, the long-term survival in cancer patients is far from optimal. Evidences suggest that choice of anaesthetics during surgery, that is, either inhalational or intravenous anaesthetics, may influence outcomes. However, the impact of general anaesthesia type on the occurrence of postoperative delirium is inconclusive. Although retrospective studies suggest that propofol-based intravenous anaesthesia was associated with longer survival after cancer surgery when compared with inhalational anaesthesia, prospective studies as such are still lacking. The purposes of this randomised controlled trial are to test the hypotheses that when compared with sevoflurane-based inhalational anaesthesia, propofol-based intravenous anaesthesia may reduce the incidence of early delirium and prolong long-term survival in elderly patients after major cancer surgery.Methods and analysisThis is a multicentre, open-label, randomised controlled trial with two parallel arms. 1200 elderly patients (≥65 years but <90 years) who are scheduled to undergo major cancer surgery (with predicted duration ≥2 hours) are randomised to receive either sevoflurane-based inhalational anaesthesia or propofol-based intravenous anaesthesia. Other anaesthetics and supplemental drugs including sedatives, opioids and muscle relaxants are administered in both arms according to routine practice. The primary early outcome is the incidence of 7-day delirium after surgery and the primary long-term outcome is the duration of 3-year survival after surgery.Ethics and disseminationThe study protocol has been approved by the Clinical Research Ethics Committees of Peking University First Hospital (2015[869]) and all participating centres. The results of early and long-term outcomes will be analysed and reported separately.Trial registration numberChiCTR-IPR-15006209;NCT02662257;NCT02660411.

scholarly journals Correction to: The effect of pre- and post-operative physical activity on recovery after colorectal cancer surgery (PHYSSURG-C): study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Aron Onerup ◽  
Eva Angenete ◽  
David Bock ◽  
Mats Börjesson ◽  
Monika Fagevik Olsén ◽  
...  
Keyword(s):  
Physical Activity ◽  
Colorectal Cancer ◽  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Cancer Surgery ◽  
Colorectal Cancer Surgery ◽  
Randomised Controlled

An amendment to this paper has been published and can be accessed via the original article.

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 HOMESIDE: home-based family caregiver-delivered music and reading interventions for people living with dementia: protocol of a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e031332 ◽  
Author(s):  
Felicity Anne Baker ◽  
Jodie Bloska ◽  
Sabine Braat ◽  
Anna Bukowska ◽  
Imogen Clark ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Psychological Symptoms ◽  
Controlled Trial ◽  
Well Being ◽  
Resource Utilisation ◽  
Home Setting ◽  
Randomised Study ◽  
People With Dementia ◽  
Home Based ◽  
Randomised Controlled

IntroductionPharmacological interventions to address behavioural and psychological symptoms of dementia (BPSD) can have undesirable side effects, therefore non-pharmacological approaches to managing symptoms may be preferable. Past studies show that music therapy can reduce BPSD, and other studies have explored how formal caregivers use music in their caring roles. However, no randomised study has examined the effects on BPSD of music interventions delivered by informal caregivers (CGs) in the home setting. Our project aims to address the need for improved informal care by training cohabiting family CGs to implement music interventions that target BPSD, and the quality of life (QoL) and well-being of people with dementia (PwD) and CGs.Methods and analysisA large international three-arm parallel-group randomised controlled trial will recruit a sample of 495 dyads from Australia, Germany, UK, Poland and Norway. Dyads will be randomised equally to standard care (SC), a home-based music programme plus SC, or a home-based reading programme plus SC for 12 weeks. The primary outcome is BPSD of PwD (measured using the Neuropsychiatric Inventory-Questionnaire). Secondary outcomes will examine relationship quality between CG and PwD, depression, resilience, competence, QoL for CG and QoL for PwD. Outcomes will be collected at baseline, at the end of the 12-week intervention and at 6 months post randomisation. Resource Utilisation in Dementia will be used to collect economic data across the life of the intervention and at 6-month follow-up. We hypothesise that the music programme plus SC will generate better results than SC alone (primary comparison) and the reading programme plus SC (secondary comparison).Ethics and disseminationEthical approval has been obtained for all countries. Results will be presented at national and international conferences and published in scientific journals and disseminated to consumer and caregiver representatives and the community.Trial registration numbersACTRN12618001799246p; NCT03907748

Sign in / Sign up

Export Citation Format

Share Document