Search Results for: Il delirium

Introduction
Prehabilitation aims to improve preoperative health before surgery to reduce complications. Reducing anxiety helps prevent postoperative pain, stress and sleep disturbances. Listening to music through headphones or earpieces in the hospital directly preoperatively, intraoperatively and postoperatively has been shown to ameliorate anxiety, stress, pain and sleep disorders. This randomised controlled trial will investigate the effect of active music listening at home 1 week before surgery as a prehabilitation modality on preoperative anxiety compared with standard care.

Methods and analysis
This study is a multicentre randomised controlled trial that will include 116 patients. The study population consists of adults undergoing elective oncological colorectal surgery. The intervention group will be advised to listen to recorded music three times per day for 20 min, starting 1 week prior to surgery, using headphones or earpieces. Both groups will receive standard care during hospitalisation. The primary outcome is patient-reported preoperative anxiety using the State-Trait Anxiety IndexInventory 6. Secondary outcomes are patient-reported stress, delirium incidence, medication usage, postoperative pain, complication rate, length of stay, adherence to the intervention, quality of life and healthcare-related costs.

Ethics and dissemination
This study protocol has been approved by the Medical Ethical Review Board of Erasmus Medical Center on 15 December 2022 (MEC-2022-9415). The trial will be carried out following the updated Declaration of Helsinki principles and Good Clinical Practice guidelines. Study results will be published and reported in a peer-reviewed journal according to the Consolidated Standards of Reporting Trials guidelines.

Trial registration number
NCT05982184.

Introduction
Delirium is a common and serious condition that frequently affects patients in the intensive care unit (ICU). It is characterised by an acute disturbance in cognition, attention and awareness that develops over a short period of time and tends to fluctuate in severity. Patients with ICU delirium (ICUD) may experience confusion, disorientation, difficulty focusing and perceptual disturbances such as hallucinations or delusions. The prevalence of ICUD is high, with estimates suggesting that it can affect up to 70% of ICU patients. The development of ICUD is associated with several adverse outcomes, including prolonged ICU and hospital stays, increased healthcare costs, higher mortality rates and an increased risk of long-term cognitive impairment, including dementia. It is unclear which components should be included in a complex intervention to prevent and manage ICUD. Furthermore, we need to understand how the different components have been implemented and their impact on clinical practice.

Methods and analysis
The review will be reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis Protocols (PRISMA-P) and the enhancing transparency in reporting the synthesis of qualitative research (ENTREQ) reporting recommendations. We will perform systematic searches to identify relevant interventions and implementation strategies for the prevention or management of ICUD. We will assess primary research, service evaluations and audits for the use of the Standards for QUality Improvement Reporting Excellence (SQUIRE) as a checklist for quality improvement in healthcare. We will extract both qualitative and quantitative data and assess study quality using the Critical Appraisal Skills Programme (CASP) tool. Our findings will be synthesised using a best-fit framework synthesis mapped against the Theoretical Domains Framework (TDF). Our Patient and Public Involvement (PPI) group will contribute to the development of review processes such as the research question and methodology and will help to evaluate which outcomes are most important.

Ethics and dissemination
No ethical approval is required for this study. The results of this systematic review of implementation strategies will be disseminated through peer-reviewed publications and conferences. They will also form part of an evidence map and logic model for factors that can improve the implementation of strategies for prevention, identification and management of ICUD.

PROSPERO registration number
CRD42024537313.

Introduction
Postoperative delirium (POD) is a frequent complication in elderly surgical patients, leading to increased morbidity and mortality. Previous studies have shown that noise isolation is associated with a reduced incidence of delirium in the intensive care unit (ICU). This trial aims to evaluate the impact of noise isolation using noise-cancelling headphones on the incidence of POD in elderly patients undergoing hip surgery.

Methods and analysis
In this randomised controlled trial, a total of 320 elderly patients will be randomised to a noise isolation group or a control group, in a 1:1 ratio and stratified by age (65-80 years or >80 years), type of surgery (fracture or non-fracture) and planned ICU admission (yes or no). For patients in the noise isolation group, noise-cancelling headphones will be used throughout anaesthesia and in the postoperative care unit or ICU. Patients in the control group will be routinely managed and exposed to the clinical environment. The primary outcome is the incidence of POD during 0-7 days after surgery or before hospital discharge, assessed using the 3 min Confusion Assessment Method or the Confusion Assessment Method for the Intensive Care Unit. The secondary outcomes include postoperative pain at 6, 24 and 48 hours after surgery; sleep quality on the first and second nights after surgery; incidence of nausea and vomiting within 48 hours postoperatively; and cognitive function and mortality at 30 days after surgery.

Ethics and dissemination
The trial was approved by the Ethics Committee of the First Affiliated Hospital of Soochow University (Approval No. 2024–054). The results of this trial will be submitted for peer review and publication in a scientific journal.

Trial registration number
Chinese Clinical Trial Registry (ChiCTR2400082211).

Introduction
Postoperative delirium (POD) is a frequent complication in elderly patients undergoing major surgery. Research has shown that neuroinflammation, postoperative pain and autonomic nervous system dysfunction play significant roles in its onset. Vagus nerve stimulation (VNS) has the potential to reduce inflammation, ease postoperative pain and aid in recovery by enhancing acetylcholine release and activating the cholinergic anti-inflammatory pathway. This study aims to assess the effectiveness and safety of transauricular VNS (ta-VNS) in preventing POD in elderly patients undergoing major surgery.

Methods and analysis
This multicentre, participant-blinded and assessor-blinded, randomised, parallel-group controlled trial will compare the incidence of POD in elderly patients undergoing major surgery who receive ta-VNS versus sham stimulation. A total of 300 eligible patients will be randomly assigned in a 1:1 ratio to either the active or sham stimulation group. The active stimulation group will receive electrical stimulation to the left cymba conchae at a frequency of 30 Hz and a pulse width of 250 µs, with a 30 s on/30 s off cycle. The intensity will start at 0.4V and be increased in 0.4V increments until a tingling sensation is felt, then adjusted to the highest tolerable level without pain. After obtaining informed consent and randomisation, the initial intervention will begin in the preoperative area and continue throughout the surgery. For the four postoperative days, the intervention will be administered twice daily in 2-hour sessions each morning and afternoon. The sham group will follow the same procedure, with electrodes placed on the left cymba conchae. After adjusting the stimulation intensity, the device will be switched off. The primary outcome is the incidence of POD from postoperative day 0 to day 7 or discharge. Secondary outcomes include the severity of POD, quality of recovery, sleep quality and adverse events.

Ethics and dissemination
The protocol was approved by Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine on 9 January 2024 (Approval number: 20240014), and the trial was registered on the Chinese Clinical Trial Registry on 21 February 2024, prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. Written informed consent will be obtained from all participants. The results will be submitted for publication in a refereed journal.

Trial registration number
ChiCTR2400081078.

Introduction
Postoperative delirium (POD) remains a prevalent neurological complication among elderly patients following major surgeries, with limited effective preventive measures currently available. Stellate ganglion block (SGB) is widely employed in clinical practices to manage various conditions by modulating the sympathetic nervous system activity. However, there is currently a lack of clinical evidence assessing its effect on the incidence of POD. This study aims to evaluate the safety and efficacy of SGB as a preventive strategy for POD in elderly patients undergoing major surgeries.

Methods and analysis
This randomised controlled clinical trial will be conducted at two centres, enrolling a total of 300 elderly patients aged 65 years and older who are scheduled for elective major surgery. Participants will be randomly assigned to either the SGB group (n=150) or the control group (n=150). In the SGB group, participants will receive an ultrasound-guided SGB using 7 mL of local anaesthetic, while the control group will receive 2 mL of saline injected into the muscle tissue on the anterolateral side of the SG. The primary outcome will be the occurrence of POD within 7 days postsurgery or before discharge. POD will be assessed two times per day using either the confusion assessment method (CAM) or the CAM for the intensive care unit. Secondary outcomes will include the severity of POD, postsurgical sleep quality, overall recovery quality and the incidence of adverse events.

Ethics and dissemination
The trial protocol has been approved by the Ethics Committees of the Affiliated Hospital of Jiaxing University (approval number 2023-KY-479) and Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (approval number 2023–0747). Written informed consent will be obtained from all participants prior to study inclusion. Data collected will be disseminated at scientific conferences and published in peer-reviewed journals.

Trial registration number
ChiCTR 2300077883.

Introduction
Postoperative delirium (POD) remains a prevalent neurological complication among elderly patients following major surgeries, with limited effective preventive measures currently available. Stellate ganglion block (SGB) is widely employed in clinical practices to manage various conditions by modulating the sympathetic nervous system activity. However, there is currently a lack of clinical evidence assessing its effect on the incidence of POD. This study aims to evaluate the safety and efficacy of SGB as a preventive strategy for POD in elderly patients undergoing major surgeries.

Methods and analysis
This randomised controlled clinical trial will be conducted at two centres, enrolling a total of 300 elderly patients aged 65 years and older who are scheduled for elective major surgery. Participants will be randomly assigned to either the SGB group (n=150) or the control group (n=150). In the SGB group, participants will receive an ultrasound-guided SGB using 7 mL of local anaesthetic, while the control group will receive 2 mL of saline injected into the muscle tissue on the anterolateral side of the SG. The primary outcome will be the occurrence of POD within 7 days postsurgery or before discharge. POD will be assessed two times per day using either the confusion assessment method (CAM) or the CAM for the intensive care unit. Secondary outcomes will include the severity of POD, postsurgical sleep quality, overall recovery quality and the incidence of adverse events.

Ethics and dissemination
The trial protocol has been approved by the Ethics Committees of the Affiliated Hospital of Jiaxing University (approval number 2023-KY-479) and Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (approval number 2023–0747). Written informed consent will be obtained from all participants prior to study inclusion. Data collected will be disseminated at scientific conferences and published in peer-reviewed journals.

Trial registration number
ChiCTR 2300077883.

Introduction
Postoperative delirium occurs in up to 40% of older surgical patients and has been associated with prolonged hospital stays, long-term cognitive impairment and increased 1-year postoperative mortality. Postoperative sleep disturbances may increase the risk of delirium, but studies investigating pharmacotherapies to improve postoperative sleep to prevent delirium remain limited. Suvorexant is a selective antagonist of orexin 1 and 2 receptors and is approved for insomnia pharmacotherapy by the Food and Drug Administration. It has the potential to improve postoperative sleep and reduce postoperative delirium rates, but randomised controlled trials (RCTs) are needed to determine the efficacy of postoperative suvorexant administration. The REPOSE study (reducing delirium by enhancing postoperative sleep with suvorexant) is a single-centre, randomised, double-blinded RCT that aims to evaluate the efficacy of suvorexant in increasing total sleep time (TST) and decreasing delirium severity in older patients undergoing non-cardiac surgery.

Methods and analysis
REPOSE will enroll 130 patients (aged ≥65 years) undergoing non-cardiac surgery with a planned postoperative inpatient stay. Participants will be randomised to receive 20 mg oral suvorexant or placebo nightly on postoperative nights 0, 1 and 2. The primary endpoint is TST on the first postoperative night, as measured using an electroencephalography headband. The secondary endpoint is peak postoperative delirium severity as measured by the 3-minute diagnostic interview for the confusion assessment method severity scores. Primary endpoint data will be analysed with a two-sample t-test using an intent-to-treat approach to compare TST on the first night that a patient received a study drug dose. Secondary and exploratory endpoint data will be analysed using two-sample t-tests between groups.

Ethics and dissemination
Ethical approval was obtained from the Duke Institutional Review Board (protocol #00111869). Results of the REPOSE study will be published in a peer-reviewed journal and presented at academic conferences. Trial data will be deposited in ClinicalTrials.gov.

Trial registration number
NCT05733286.

Introduction
Postoperative delirium (POD) is a common complication after hip fracture surgery in older patients. Esketamine may be beneficial in alleviating the occurrence of POD. Our trial aim is to investigate whether the intravenous administration of esketamine can improve POD in older patients undergoing surgery for hip fracture.

Methods and analysis
This randomised controlled trial will be conducted at the Chengdu Integrated TCM & Western Medicine Hospital in Chengdu, China. A total of 260 older patients scheduled for hip fracture surgery under general anaesthesia will be randomly allocated to either an esketamine group (group E) or a control group (group C) at a 1:1 ratio (n=130 in each group). After tracheal intubation, group E will receive continuous infusion of esketamine at a rate of 0.3 mg/kg/h intraoperatively until the beginning of skin incision closure. Group C will receive equivalent volumes and rates of 0.9% normal saline; the injection methods are in accordance with those in group E. The primary outcome is the incidence of POD within 3 days after surgery, which will be evaluated using the confusion assessment method two times per day. Secondary outcomes are subtypes, duration of delirium, length of hospital stay, pain severity score within 3 days after surgery and 30-day all-cause mortality. Pain severity scores at rest will be evaluated using a numeric rating scale. Safety outcomes will include hallucination, dizziness, nightmares, nausea and vomiting. All analyses will be performed in line with the intention-to-treat principle.

Ethics and dissemination
Ethics approval was obtained from the Medical Ethics Committee of Chengdu integrated TCM & Western Medicine Hospital (2024KT022). All patients will provide written informed consent before enrolment. The results of the trial will be published in an appropriate journal or an oral presentation at academic meetings.

Trial registration number
Chinese Clinical Trial Registry (ChiCTR2400081681).

Introduction
Acute sleep and circadian rhythm (SCR) disruption can lead to a range of negative physical and mental consequences, such as depression, delirium, respiratory dysfunction and increased mortality. In the intensive care unit (ICU), the unique environment can exacerbate disruptions in SCR. Few studies have identified the characteristics of SCR in the ICU, and the roles of patient characteristics, illness and medical interventions in ICU SCR remain unclear. A single-centre prospective cohort study, called SYNC study (Sleep and circadian rhYthm in iNtensive Care unit), will be conducted to explore the characteristics and associated factors of SCR and investigate the short-term prognosis among patients in the surgical ICU.

Methods and analysis
Patients from a surgical ICU at a tertiary teaching hospital will be enrolled. SCR will be assessed by both objective and subjective indicators, including melatonin secretion rhythm, activity rhythm, sleep pattern and perceived sleep quality. Data on eight potential factors that influence SCR, including light exposure, noise level, pain level, nighttime disturbances, mechanical ventilation, sedative and analgesic use, meal pattern and restraints, will be collected. These data will be gathered in the first 3 days after ICU admission. Short-term prognostic indicators, including anxiety, depression, cognitive function, insomnia, activities of daily living, ICU stay, hospital stay and hospital mortality will be collected during the hospital stay and at 1 month after discharge.

Ethics and dissemination
The study has been approved by the Ethics Committee of Zhongshan Hospital, Fudan University (B2024-076R). The results of this study will be published in peer-reviewed journals.

Trial registration number
NCT06346613.

Objective
This study aims to define the prioritisation of the needs for an intelligent robot’s functions in the intensive care unit (ICU) from a clinical perspective.

Design
This study introduces a nominal group technique.

Setting
This study uses national setting.

Participants
This study includes a total of 851 respondents from 34 provinces in China who participated in the survey. A nominal group of 12 members was organised by the research group; there were seven experts with a background in critical care, two junior attending physicians with a background in critical care and three experienced nurses.

Results
A total of 50 needed intelligent robot functions in ICUs were obtained from the questionnaire data. Through three rounds of nominal group voting and discussion, a consensus was reached on 44 items, which were categorised into 29 high-priority needs, 13 medium-priority needs and two low-priority needs. The functionalities in areas such as ‘sleep and pain assessment,’ ‘monitoring of sedation, agitation, and delirium,’ and ‘robot-assisted rehabilitation and physical therapy’ were particularly favoured by the ICU medical and nursing staff.

Conclusions
This study has defined the functional needs and priorities for ICU intelligent robots from the perspective of ICU clinical medical and nursing staff. It has been concluded that ‘disease assessment function’ and ‘rehabilitation and physical therapy’ are most needed by clinical doctors and nurses. The results presented in this study could serve as a useful reference for future research and development of medical robots.

Introduction
Remimazolam is a novel short-acting benzodiazepine that exhibits sedative and hypnotic properties without compromising respiratory function and while maintaining haemodynamic stability. Its safety and efficacy have been demonstrated to be non-inferior to those of propofol in the context of general anaesthesia. Nevertheless, the non-inferiority in terms of postoperative recovery quality in obese patients has not been established. Thus, we conducted a prospective, randomised, parallel-group, non-inferiority study to compare remimazolam-based general anaesthesia with propofol-based general anaesthesia on the postoperative quality of recovery (QoR) in patients undergoing laparoscopic sleeve gastrectomy.

Methods and analysis
All participants meeting the included criteria will be enrolled after signing an informed consent form. Patients will be randomly allocated to either the propofol group (n=63; induction and maintenance with propofol) or the remimazolam group (n=63; induction and maintenance with remimazolam). The primary endpoint of the study is the 15-item QoR Scale assessed at 24 hours postoperatively. Secondary endpoints include the doses of anaesthetic required for loss of consciousness (LOC), the time to LOC, the time to recovery of consciousness, the total amount of anaesthetic administered during the surgery and the incidence of hypotension and bradycardia. Additionally, postoperative profiles of pain, nausea and vomiting, delirium, intraoperative awareness, adverse events and patient satisfaction will be collected. Statistical analyses will be performed using IBM SPSS Statistics V.26.0 and GraphPad Prism V.5.01. Statistical significance is set at two-sided p values

Introduction
Delirium, a common neuropsychiatric condition in hospitalised older adults, is associated with increased mortality, longer hospital stays and cognitive decline. The potential of melatonin to prevent delirium by improving sleep patterns and regulating circadian rhythms is promising, though existing evidence is mixed. This study aims to evaluate the efficacy of melatonin in preventing delirium in medically hospitalised patients aged 65 years and older.

Methods and analysis
This randomised, double-blind, placebo-controlled trial will enrol 240 patients aged 65 or older admitted to general medical wards at Sultan Qaboos University Hospital starting from September 2024. Participants will be randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days. The primary outcome is the incidence of delirium, assessed using the 3 min Diagnostic Confusion Assessment Method during the first 5 days. Secondary outcomes include the duration of delirium, sleep patterns and other clinical measures, such as hospital length of stay and 28-day readmission.

Ethics and dissemination
The study protocol has received ethical approval from the Medical Research Ethics Committee at Sultan Qaboos University (REF. NO. SQU-EC/0242024, MREC #3240). All participants or their legal proxies will provide informed consent prior to enrolment. Results will be disseminated through peer-reviewed publications and conference presentations, contributing to the global evidence base on delirium prevention strategies in hospitalised older adults.

Trial registration number
ClinicalTrials.gov under the identifier NCT06509191.

In Reply We thank Drs Lieberman and LaHue for highlighting the importance that delirium has in the postoperative period of cardiac surgery, with a reported prevalence of up to 25% to 50%. We agree that organ dysfunction in patients undergoing cardiac surgery, especially those requiring cardiopulmonary bypass, must be evaluated as a whole picture and not only focused on a single organ end point. It seems very attractive to analyze the possible effect that a hypothetical removal of inflammatory mediators and damage-associated molecular patterns with the use of a nonselective EBP during cardiopulmonary bypass may have on the incidence of delirium. Previous data from the REMOVE trial point in this direction, although the EBP device used and the EBP settings (eg, blood flow) were different from those in our study. Nonselective EBP devices are capable of removing a large amount of molecules from the circulation, and this must be considered when performing the technique because some previously reported adverse effects (thrombocytopenia or heparin adsorption) could appear with the use of high blood flow.

Background
Postoperative delirium (POD) is an acute neurocognitive impairment and is commonly observed in older patients with hip fractures. POD is associated with poor outcomes, including increased postoperative complications, prolonged hospitalisation, high costs and increased perioperative mortality. Therefore, reducing the occurrence of POD and improving cognitive abilities in older patients are critical and urgent. Transcutaneous auricular vagus nerve stimulation (TAVNS) is a simple, safe, non-invasive treatment and has great potential to improve cognitive function. This clinical study will evaluate the effectiveness of TAVNS in reducing the incidence of POD in older patients and further elucidate the possible underlying mechanisms.

Methods and analysis
This randomised, double-blind, single-centre controlled trial will enroll 154 older patients undergoing hip fracture surgery, who will be randomly assigned to the TAVNS group (n=77), receiving TAVNS from 1 hour before anaesthetic induction to the end of the surgery, or the sham stimulation group (n=77), receiving sham stimulation in the same manner. The primary outcome measure will be the incidence of POD during the first 7 days post-surgery, as assessed by the confusion assessment method for the intensive care unit. The secondary outcomes include the incidence of delayed neurocognitive recovery; serum acetylcholinesterase and butyrylcholinesterase levels; the concentrations of tumour necrosis factor-α, interleukin-1β, interleukin-6 and S100β; unplanned intensive care unit admission rates; the length and cost of hospital stay; the incidence of postoperative complications during hospitalisation; and mortality at 1 month, 6 months and 1 year after surgery.

Ethics and dissemination
This study was approved by the Ethics Committee of the Chongqing Traditional Chinese Medicine Hospital on 15 May 2024 (2024-KY-HY-13). The findings will be published in the international peer-reviewed academic journals and presented orally at academic conferences.

Trial registration number
ChiCTR2400085508.

Recommendations focus on delirium risk and prevention.

Introduction
Intensive care unit (ICU) delirium is an acute brain dysfunction that affects up to 7 out of 10 patients admitted to ICUs. Patients who develop ICU delirium cannot think clearly, have trouble paying attention, do not understand what is happening around them and may see or hear things that are not there. ICU delirium increases the time patients spend in ICUs and hospitals and therefore healthcare costs. ICU delirium is also associated with increased mortality and dementia in the longer term. ICU delirium prevention and management strategies are likely to include both pharmacological and non-pharmacological components as part of a complex intervention, but it is unclear which components should be included. The objective of this meta-review is to systematically map the quantity and certainty of the available evidence from reviews and meta-analyses of randomised controlled trials (RCTs) of pharmacological and non-pharmacological interventions, which will be used to design a multicomponent intervention to prevent and manage ICU delirium.

Methods and analysis
A systematic search strategy was performed in MEDLINE (Ovid), Embase (Elsevier), Cochrane Database of Systematic Reviews, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO and Web of Science (from inception to 26 September 2023), as well as Epistemonikos (from inception to 19 July 2023). We will include all critically ill adults (aged≥18 years) and any ICU delirium prevention or management intervention (pharmacological or non-pharmacological). For pharmacological interventions, we will include reviews of RCTs. For non-pharmacological interventions, we will consider reviews of RCTs, quasi-experimental and cohort studies. We will use the International Consensus Study (Del-COrS) core outcome set for research evaluating interventions to prevent or manage ICU delirium and synthesise our findings using quantitative data description methods. We will involve our Patient and Public Involvement group of people who experienced ICU delirium to develop and comment on such aspects as the research question, methodology and which outcomes are most important.

Ethics and dissemination
No ethical approval is required for this study. The results of this meta-review will be disseminated through peer-reviewed publications and conferences. They will also form part of an evidence map and logic model for the prevention and management of ICU delirium.

PROSPERO registration number
CRD42023473260