HFE genotypes, haemochromatosis diagnosis and clinical outcomes at age 80 years: a prospective cohort study in the UK Biobank

Objectives
HFE haemochromatosis genetic variants have an uncertain clinical penetrance, especially to older ages and in undiagnosed groups. We estimated p.C282Y and p.H63D variant cumulative incidence of multiple clinical outcomes in a large community cohort.

Design
Prospective cohort study.

Setting
22 assessment centres across England, Scotland, and Wales in the UK Biobank (2006–2010).

Participants
451 270 participants genetically similar to the 1000 Genomes European reference population, with a mean of 13.3-year follow-up through hospital inpatient, cancer registries and death certificate data.

Main outcome measures
Cox proportional HRs of incident clinical outcomes and mortality in those with HFE p.C282Y/p.H63D mutations compared with those with no variants, stratified by sex and adjusted for age, assessment centre and genetic stratification. Cumulative incidences were estimated from age 40 years to 80 years.

Results
12.1% of p.C282Y+/+ males had baseline (mean age 57 years) haemochromatosis diagnoses, with a cumulative incidence of 56.4% at age 80 years. 33.1% died vs 25.4% without HFE variants (HR 1.29, 95% CI: 1.12 to 1.48, p=4.7×10-4); 27.9% vs 17.1% had joint replacements, 20.3% vs 8.3% had liver disease, and there were excess delirium, dementia, and Parkinson’s disease but not depression. Associations, including excess mortality, were similar in the group undiagnosed with haemochromatosis. 3.4% of women with p.C282Y+/+ had baseline haemochromatosis diagnoses, with a cumulative incidence of 40.5% at age 80 years. There were excess incident liver disease (8.9% vs 6.8%; HR 1.62, 95% CI: 1.27 to 2.05, p=7.8×10-5), joint replacements and delirium, with similar results in the undiagnosed. p.C282Y/p.H63D and p.H63D+/+ men or women had no statistically significant excess fatigue or depression at baseline and no excess incident outcomes.

Conclusions
Male and female p.C282Y homozygotes experienced greater excess morbidity than previously documented, including those undiagnosed with haemochromatosis in the community. As haemochromatosis diagnosis rates were low at baseline despite treatment being considered effective, trials of screening to identify people with p.C282Y homozygosity early appear justified.

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Efficacy of epidural esketamine on postoperative sleep quality after laparoscopic and robotic lower abdominal surgeries: a study protocol for randomised, double-blind, controlled trial

Introduction
Postoperative sleep disturbances significantly impair postoperative recovery. The administration of intravenous esketamine has been shown to potentially improve postoperative sleep quality. However, the effectiveness of epidural esketamine in improving postoperative sleep quality remains to be elucidated. This study aims to explore the impact of both intraoperative and postoperative use of epidural esketamine on the postoperative sleep quality of patients undergoing minimally invasive lower abdominal surgeries.

Methods and analysis
This randomised, double-blind, parallel-group, placebo-controlled trial will be conducted at the Fudan University Shanghai Cancer Centre. A total of 128 adults undergoing minimally invasive lower abdominal surgeries will be randomly allocated in a 1:1 ratio to either the esketamine group or the placebo group. In the esketamine group, epidural esketamine will be administered intraoperatively (0.2 mg/kg) and postoperatively (25 mg). Postoperatively, all patients will receive epidural analgesia. The primary outcome of the study is the incidence of poor sleep quality on the third day after surgery. The sleep quality assessment will be conducted using the Pittsburgh Sleep Quality Index and a Numeric Rating Scale of sleep. The main secondary outcomes include postoperative pain and anxiety and depression scores. The postoperative pain, both rest pain and movement pain, will be assessed using a Numerical Rating Scale within 5 days after surgery. Anxiety and depression scores will be evaluated using the Hospital Anxiety and Depression Scale both before and after the surgery. Safety outcomes will include delirium, fidgeting, hallucinations, dizziness and nightmares. The analyses will be performed in accordance with intention-to-treat principle

Ethics and dissemination
Ethics approval has been obtained from the Ethics Committee of the Shanghai Cancer Centre (2309281-9). Prior to participation, all patients will provide written informed consent. The results of the trial are intended to be published in a peer-reviewed journal.

Trial registration number
ChiCTR2300076862.

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Cefepime vs Piperacillin-Tazobactam for Acute Infection in Hospitalized Adults

To the Editor A recent randomized clinical trial compared empirical cefepime vs piperacillin-tazobactam in adult patients who presented to the hospital with suspected infection. However, we urge caution in accepting the authors’ conclusion that empirical use of cefepime resulted in more neurological dysfunction vs piperacillin-tazobactam. This conclusion was based on the finding that patients in the cefepime group experienced fewer days alive and free of delirium and coma within 2 weeks, with a mean difference of only 0.3 days (odds ratio [OR], 0.79 [95% CI, 0.65-0.95]).

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Abstract WMP57: Systematic Reduction of Neurochecks Overnight Decreases Length of Stay and Post-Stroke Delirium

Stroke, Volume 55, Issue Suppl_1, Page AWMP57-AWMP57, February 1, 2024. Introduction:Post-stroke delirium is common and leads to worse short- and long-term outcomes with higher 28-day modified Rankin Score (mRS), longer length of hospitalization, and increased odds of discharge to a nursing home, development of dementia, and death. Circadian rhythm disturbances have been implicated as a core mechanism in the pathogenesis of delirium as well as a common sequela of stroke. Standard of care for acute stroke patients is to receive q1h-q4h neuro checks overnight to ensure stability and these are typically continued throughout hospitalization; however, there is limited evidence to support extended use and frequent checks have been implicated in increased delirium rate. Our pilot study addresses this problem by proactively holding neuro checks overnight on clinically stable patients with the goal of promoting re-institution of circadian rhythm as a delirium prevention measure.Methods:After at least 24 hours of hospitalization, patients who were felt to be clinically stable had neuro checks discontinued overnight between the hours of 8pm and 4am and efforts were made to bundle care around these times. If patients were felt not to be stable enough to reduce neuro checks, neuro checks were continued at the frequency typical of the usual standard of care. Patients were reassessed daily to determine if they were stable for neuro check decrease. The Confusion Assessment Method (CAM) was performed each shift with a positive result indicative of delirium.Results:290 patients over 12 months were included in the analysis (157 pre-intervention, 133 post-intervention). Demographic data did not differ significantly between groups. After the intervention was initiated, CAM positivity decreased from 34% to 23% (p=0.017). LOS decreased from 6.6 days to 5.1 days (p=0.024). mRS and NIHSS during hospitalization did not significantly change (NIHSS p=0.97, mRS p=0.38).Conclusions:After the introduction of the intervention, delirium rate and length of stay decreased significantly. In conclusion, holding neuro checks overnight for clinically stable patients may decrease delirium rate and length of stay, but require more systematic study.

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Abstract TP22: Delirium, Infection, and Risk of Dementia in Patients With and Without Cerebral Small Vessel Disease

Stroke, Volume 55, Issue Suppl_1, Page ATP22-ATP22, February 1, 2024. Background:The increased risk of dementia after delirium and infection might be influenced by cerebral small vessel disease-SVD. We determined associations between hospitalisations with delirium, and with infection on follow-up after TIA/minor stroke and 5-year dementia risk, stratified by moderate/severe SVD on baseline brain imaging.Methods:In a population-based study (n=94 567) of TIA/minor stroke (NIHSS

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Abstract WP10: Impact of Dexmedetomidine in Neurocritical Care on Outcomes of Ischemic Stroke Patients With Large Vessel Occlusion

Stroke, Volume 55, Issue Suppl_1, Page AWP10-AWP10, February 1, 2024. Introduction:While observational data suggest that dexmedetomidine may have neuroprotective effects on ischemic brain, its clinical use in acute ischemic stroke is limited due to concerns about cerebral vasoconstriction. We aimed to examine the impact of dexmedetomidine on outcomes in patients with anterior circulation large vessel occlusion (acLVO) requiring neurocritical care after endovascular therapy (EVT).Methods:We extracted data from our stroke registry for consecutive patients with acLVO who underwent EVT and subsequent neurocritical care (12/2019-12/2022). Patients were categorized based on dexmedetomidine treatment. Intravenous dexmedetomidine was given alone or adjunctively for endotracheal tube intolerance, withdrawal symptoms, sedation transition and delirium. Primary outcomes were favorable functional status (mRS≤2) and mortality at 90 days.Results:Of 402 patients, 76 (18.9%) received dexmedetomidine after a median of 4 [3] days post-stroke. Dexmedetomidine-treated patients were more often male (63.2% vs. 45.4%; p=0.01), had higher baseline NIHSS scores (17 [7] vs. 15 [9.5]; p=0.001), lower baseline ASPECTS (7 [3] vs. 8 [2]; p

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Abstract TP167: Hemorrhage Severity Associates With Hospital Acquired Delirium During Intracerebral Hemorrhage

Stroke, Volume 55, Issue Suppl_1, Page ATP167-ATP167, February 1, 2024. Introduction:Delirium associates with poor outcome after intracerebral hemorrhage (ICH), yet its incidence and contributing factors are poorly characterized. We show delirium proportions among older ICH patients and identify factors that associate with hospital-acquired delirium (HAD).Methods:Data from older adult (≥70 years) patients with primary nontraumatic ICH were retrieved from electronic medical records. Delirium was assessed once every 12 hours or per shift using the modified Arousal, Attention, Abbreviated Mental Test-4, Acute change test. Delirium on admission (DOA) was defined as a positive screen within 48 hours of admission and HAD was defined as a positive screen among non-DOA patients. Population differences between HAD and non-HAD patients were assessed using Wilcoxon Rank Sum and Pearson’s Chi Squared tests. Factors associated with HAD were identified via multivariable logistic regression modelling. Adjusted odds ratios (aOR) and 95% confidence intervals (CI) are reported.Results:The cohort included 647 patients (median age: 79, interquartile range: [74-85]; 55.0% female) with an ethno-racial distribution of 57.6% White, 16.4% Black, 15.9% Hispanic, 8.5% Asian, and 1.6% Other. The median hemorrhage volume was 8.0 [1.6-24.7] cm3. DOA was present in 327 (50.5%) patients. Among patients without DOA (n=320), 90 (28.1%) developed HAD. In univariate analyses, patients with HAD (vs non-HAD) were significantly older and had lower admission Glasgow Coma Scale scores, larger hemorrhages volumes, more frequent intraventricular hemorrhage (IVH), and longer lengths of stay. In multivariable modelling, HAD was independently associated with older age (1.05 [1.01-1.10]), top-quartile hemorrhage volume (2.89 [1.08-7.75]), length of stay (1.14 [1.08-1.19]), and IVH (2.03 [1.08-1.19]) (Figure 1).Discussion:Older patients and those with more severe hemorrhage characteristics show greater odds of developing in-hospital delirium.

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Does pain optimisation impact delirium outcomes in critically ill patients? A systematic review and meta-analysis protocol

Background
Untreated pain is associated with short-term and long-term consequences, including post-traumatic stress disorder and insomnia. Side effects of some analgesic medications include dysphoria, hallucinations and delirium. Therefore, both untreated pain and analgesic medications may be risk factors for delirium. Delirium is associated with longer length of stay or cognitive impairment. Our systematic review and meta-analysis will examine the relationship between pain or analgesic medications with delirium occurrence, duration and severity among critically ill adults.

Methods and analysis
MEDLINE, EMBASE, CINAHL, the Cochrane Central Register of controlled trials and a review of recent conference abstracts will be searched without restriction from inception to 15 May 2023. Study inclusion criteria are: (1) age≥18 years admitted to intensive care; (2) report a measure of pain, analgesic medications and delirium; (3) study design—randomised controlled trial, quasiexperimental designs and observational cohort and case–control studies excluding case reports. Study exclusion criteria are: (1) alcohol withdrawal delirium or delirium tremens; or (2) general anaesthetic emergence delirium; or (3) lab or animal studies. Risk of bias will be assessed with the Risk of Bias V.2 and risk of bias in non-randomised studies tools. There is no language restriction. Occurrence estimates will be transformed using the Freeman-Tukey double arcsine. Point estimates will be pooled using Hartung-Knapp Sidik-Jonkman random effects meta-analysis to estimate a pooled risk ratio. Statistical heterogeneity will be estimated with the I2 statistic. Risk of small study effects will be assessed using funnel plots and Egger test. Studies will be analysed for time-varying and unmeasured confounding using E values.

Ethics and dissemination
Ethical approval is not required as this is an analysis of published aggregated data. We will share our findings at conferences and in peer-reviewed journals.

PROSPERO registration number
The finalised protocol was submitted to the International Prospective Register of Systematic Reviews (PROSPERO ID: CRD42022367715).

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Effects of liposomal bupivacaine in preoperative fascia iliac block on postoperative pain and delirium in elderly patients undergoing hip fracture surgery: a study protocol for a randomised, parallel controlled prospective clinical study

Introduction
Postoperative delirium (POD) is the most common acute fluctuating mental state change after hip fractures in older adults. Postoperative pain is a Grade A risk factor for POD and is closely related to the prognosis of patients undergoing hip fracture surgery. The fascia iliac block has a definite analgesic effect and few side effects, and several studies have reported that it reduces the occurrence of POD in patients undergoing general anaesthesia for hip fracture surgery. Liposomal bupivacaine is a local anaesthetic with a long half-life that significantly reduces the use of opioids and is conducive to patient prognosis and recovery. However, whether regional nerve block analgesia can decrease the occurrence of POD in elderly patients undergoing hip fracture surgery has not been reported.

Methods and analysis
This is a single-blinded, randomised, parallel-controlled prospective clinical study. Participants will be randomly assigned preoperatively to either the liposomal bupivacaine (ie, Exparel) or ropivacaine groups by block randomisation. Then, the occurrence of POD (primary outcome) and postoperative pain (secondary outcome) will be evaluated.

Ethics and dissemination
This research protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines and is approved by the Ethics Committee of Shanghai General Hospital (ID 2023–437). The original data are expected to be released in July 2029 on the ResMan original data-sharing platform (IPD-sharing platform) of the China Clinical Trial Registry, which can be viewed on the following website: http://www.medresman.org.cn.

PROSPERO registration number
ChiCTR2300074022.

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Study protocol for a national observational cohort investigating frailty, delirium and multimorbidity in older surgical patients: the third Sprint National Anaesthesia Project (SNAP 3)

Introduction
Older surgical patients are more likely to be living with frailty and multimorbidity and experience postoperative complications. The management of these conditions in the perioperative pathway is evolving. In order to support objective decision-making for patients, services and national guidance, accurate, contemporary data are needed to describe the impact and associations between frailty, multimorbidity and healthcare processes with patient and service-level outcomes.

Methods and analysis
The study is comprised of an observational cohort study of approximately 7500 patients; an organisational survey of perioperative services and a clinician survey of the unplanned, medical workload generated from older surgical patients. The cohort will consist of patients who are 60 years and older, undergoing a surgical procedure during a 5-day recruitment period in participating UK hospitals. Participants will be assessed for baseline frailty and multimorbidity; postoperative morbidity including delirium; and quality of life. Data linkage will provide additional details about individuals, their admission and mortality.
The study’s primary outcome is length of stay, other outcome measures include incidence of postoperative morbidity and delirium; readmission, mortality and quality of life. The cohort’s incidence of frailty, multimorbidity and delirium will be estimated using 95% CIs. Their relationships with outcome measures will be examined using unadjusted and adjusted multilevel regression analyses. Choice of covariates in the adjusted models will be prespecified, based on directed acyclic graphs.
A parallel study is planned to take place in Australia in 2022.

Ethics and dissemination
The study has received approval from the Scotland A Research Ethics Committee and Wales Research Ethics Committee 7.
This work hopes to influence the development of services and guidelines. We will publish our findings in peer-reviewed journals and provide summary documents to our participants, sites, healthcare policy-makers and the public.

Trial registration number
ISRCTN67043129.

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Intervention of muscle-building and antifrailty exercise combined with Baduanjin for frailty of different functional levels: study protocol for a randomised controlled trial

Introduction
Frailty has been currently considered as a multidimensional concept, including physical, cognitive and social frailty. Frailty has also been associated with a range of adverse events, which might increase the risks of disability, falls, fractures, delirium and death. Increasing evidence has shown that multicomponent exercise training can improve physical and cognitive function, delay or reverse frailty. However, there is still a lack of exercise intervention programmes for the frail older adults in China. This trial aims to investigate the effects of the muscle-building and antifrailty exercise combined with Baduanjin on the physical function of frail older adults, as well as the effectiveness and safety of the intervention.

Methods and analysis
This study is a prospective randomised controlled trial. A total of 192 patients, aged 70 years or older, who are diagnosed as prefrailty or frailty based on the Fried criteria will be included. Prior written and informed consent will be obtained from every subject. These subjects will be randomly assigned to the exercise intervention group (n=96) and the control group (n=96). The exercise intervention group will undergo different exercise programmes for different levels of physical function. They will perform the muscle-building and antifrailty exercise three times per week for 30–60 min for 24 weeks. The control group will implement health education on frailty and maintain the old lifestyle without any intervention.
The primary outcomes include the change in frailty and functional capacity, assessed according to the Fried Scale and the Short Physical Performance Battery. Secondary outcomes include the changes in body composition, Activities of daily living, Mini-Mental State Examination, The Geriatric Depression Scale-15 and the haematological indicators.

Ethics statement
The study has been approved by the Medical Ethics Committee of the PLA General Hospital (approval no.: S2022-600-02).

Trial registration number
ChiCTR2300070535.

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Ultrasound-guided serratus anterior plane block to prevent neurocognitive impairment in elderly patients after thoracoscopic lobectomy: protocol for a single-centre, double-blind, randomised controlled trial

Introduction
Postoperative neurocognitive dysfunction (PND), including postoperative delirium (POD), is a common complication in elderly patients after major surgeries, often leading to poor postoperative recovery. Although the pathological mechanism underlying PND is still unclear, postoperative pain is strongly associated with the development of PND. The ultrasound-guided serratus anterior plane block (SAPB) has been reported to relieve postoperative pain in thoracic surgery. Therefore, this prospective trial hypothesises that SAPB may reduce the incidence of PND in the elderly undergoing thoracoscopic lobectomy.

Methods and analysis
This study is designed as a single-centre, double-blind, randomised controlled clinical trial. A total of 256 elderly patients scheduled to undergo thoracoscopic lobectomy at Shanghai Pulmonary Hospital will be randomly assigned to general anaesthesia group or SAPB group. The primary outcome is the incidence of PND 7 days postoperatively or before discharge from hospital. The secondary outcomes include the occurrence of POD, the postoperative pain scores, Quality of Recovery at 1–2 days postoperatively and incidence of PND at 3 months postoperatively. The levels of fasting blood glucose in peripheral blood will be examined before and 1–2 days postoperatively.

Ethics and dissemination
The trial has been approved by the Clinical Research Ethics Committee of Shanghai Pulmonary Hospital (identifier: K20-290). All participants will be required to provide written informed consent before any protocol-specific procedures. Findings will be disseminated in a peer-reviewed journal and in national and/or international meetings to guide future practice.

Trial registration number
ChiCTR2100052633.

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Alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B Trial): protocol for a multicentre phase 3 pragmatic clinical and cost-effectiveness randomised trial in the UK

Introduction
Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care.

Methods and analysis
Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of –2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.
The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40–50 UK ICUs.

Ethics and dissemination
The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines.

Trial registration number
ClinicalTrials.gov NCT03653832.

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Pharmacological and non-pharmacological interventions to prevent delirium after cardiac surgery: a protocol for a systematic review and meta-analysis

Introduction
Delirium is a syndrome characterised by a disturbance in attention, awareness and cognition as a result of another physical condition. It occurs in up to 50% of patients after cardiac surgery and is associated with increased mortality, prolonged intensive care and hospital stay and long-term cognitive dysfunction. Identifying effective preventive interventions is important. We will therefore conduct a systematic review to identify all randomised controlled studies that have tested a pharmacological or non-pharmacological intervention to prevent delirium.

Methods and analysis
We will search electronic databases (CDSR (Reviews), CENTRAL (Trials), MEDLINE Ovid, Embase Ovid, PsycINFO Ovid) as well as trial registers (clinicaltrials.gov and ISCRTN) for randomised controlled trials of both pharmacological and non-pharmacological interventions designed to prevent delirium after cardiac surgery in adults. Screening of search results and data extraction from included articles will be performed by two independent reviewers using Rayyan. The primary outcome will be the incidence of delirium. Secondary outcomes include: duration of postoperative delirium, all-cause mortality, length of postoperative hospital and intensive care stay, postoperative neurological complications other than delirium, health-related quality of life and intervention-specific adverse events. Studies will be assessed for risk of bias using the Cochrane RoB2 tool. A narrative synthesis of all included studies will be presented and meta-analysis (if appropriate network meta-analysis) will be undertaken where there are sufficient studies (three or more) for pooling results. Results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Ethics and dissemination
No ethical approval is required. This review will be disseminated via peer-reviewed manuscript and conferences.

PROSPERO registration number
CRD42022369068.

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Effect of percutaneous cerebral oximetry-guided anaesthetic management on postoperative delirium in older adults undergoing off-pump coronary artery bypass grafting: study protocol for a single-centre prospective randomised controlled trial in a tertiary academic hospital in China

Introduction
Postoperative delirium is a prominent and clinically important complication in older adults after coronary artery bypass grafting (CABG) surgery, resulting in prolonged hospital stay, long-term cognitive impairment and increased morbidity and mortality. Many studies have shown that cerebral desaturation is associated with increased risk of postoperative delirium during on-pump cardiac surgery. However, few studies have focused on the effect of optimising regional cerebral oxygen saturation (rSO2) on postoperative delirium during off-pump CABG. The purpose of this study is to investigate whether intraoperative anaesthetic management based on percutaneous cerebral oximetry monitoring decreases the incidence of postoperative delirium in older adults undergoing off-pump CABG.

Methods
This single-centre randomised controlled trial will randomly assign 200 patients to the intervention group or the control group at a ratio of 1:1. The patients in the intervention group will be observed by percutaneous cerebral oximetry monitoring that the desaturation (a drop of more than 20% from baseline value or rSO2 less than 55% for >60 consecutive seconds at either probe) during the procedure triggered the intervention strategies, while the cerebral oximetry data of the control group will be hidden from the clinical team and patients will be anaesthetised by the usual anaesthetic management. The primary outcome will be the incidence of postoperative delirium during the first 7 days after off-pump CABG. Delirium will be comprehensively evaluated by the combination of the Richmond Agitation Sedation Scale and the Confusion Assessment Method for the intensive care unit. The secondary outcomes will include the incidence of postoperative acute kidney injury and myocardial infarction during the hospital stay, as well as the intensive care unit and hospital length of stay.

Ethics and dissemination
This study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences, Fuwai Hospital (No 2022–1824). Written informed consent will be obtained from each patient or their legal representatives before enrolment. The results of this trial will be published in an international peer-reviewed scientific journal.

Trial registration number
ChiCTR2300068537.

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Postoperative stellate ganglion block to reduce myocardial injury after laparoscopic radical resection for colorectal cancer: protocol for a randomised trial

Introduction
Stellate ganglion block (SGB) is usually used in the department of algiatry. But preoperative SGB may reduce adverse cardiovascular events in high-risk patients, although evidence remains sparse. Therefore, we aim to determine whether a single-shot postoperative SGB can reduce the incidence of myocardial injury after non-cardiac surgery (MINS) and improve recovery in patients undergoing laparoscopic radical resection for colorectal cancer.

Methods and analysis
This is an investigator-initiated, single-centre, randomised, two-arm clinical trial enrolling patients aged over 45 years and scheduled for elective laparoscopic radical colorectal surgery with at least one risk factor for MINS. A total of 950 eligible patients will be randomised into a routine or block groups. The primary outcome is the incidence of MINS. The secondary outcomes include the Visual Analogue Scale of pain during rest and movement, the incidence of delirium, quality of recovery (QOR) assessed by QOR-15, and sleep quality assessed by Richards Campbell Sleep Questionnaire. Tertiary outcomes include time to first flatus, gastrointestinal complications such as anastomotic leak or ileus, length of hospital stay, collapse incidence of severe cardiovascular and cerebrovascular complications of myocardial infarction, cardiac arrest, ischaemic or haemorrhagic stroke, and all-cause mortality within 30 days after the operation.

Ethics and dissemination
The protocol was approved by Medical Ethics Committee of the China-Japan Union Hospital, Jilin University (Approval number: 2021081018) prior to recruitment. The study will be performed according to the guidelines of the Declaration of Helsinki. The findings of this study will be published and presented through various scientific forums.

Trial registration number
ChiCTR2200055319.

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