Adult anaesthesia

成人麻醉
  • 文章类型: Journal Article
    背景:超声引导腰方肌阻滞常用于剖宫产术后镇痛。超声引导腰方肌阻滞可以通过四种方法进行,包括横向,后部,前,和肌内方肌阻滞。本系统综述和荟萃分析旨在确定超声引导腰方肌阻滞用于选择性剖宫产术后镇痛的最佳方法。
    方法:PubMed,EMBASE,Cochrane图书馆和WebofScience数据库将从开始到2024年7月30日进行系统搜索。将纳入随机对照试验,比较不同超声引导下的腰方肌阻滞方法在选择性剖腹产中的镇痛效果。只有英文出版物才有资格列入。术后24小时内的总镇痛消耗将是主要结果。第一次镇痛请求的时间,术后休息和运动时的疼痛评分,不良反应的发生率将是次要结局.将使用RevManV.5.4进行统计分析。网络荟萃分析将用于研究中不同方法之间的间接比较。建议评估的分级,开发和评估方法将用于评估每个结果的证据质量。
    背景:不需要道德批准。这项研究的结果将提交给同行评审的期刊。
    CRD42024503694。
    BACKGROUND: Ultrasound-guided quadratus lumborum blocks are commonly used for postoperative analgesia during caesarean section. Ultrasound-guided quadratus lumborum blocks can be performed through four approaches, including lateral, posterior, anterior, and intramuscular quadratus lumborum blocks. This systematic review and meta-analysis aims to determine the optimal approach to ultrasound-guided quadratus lumborum blocks for postoperative analgesia in elective caesarean section.
    METHODS: The PubMed, EMBASE, Cochrane Library and Web of Science databases will be systematically searched from their inception to 30 July 2024. Randomised controlled trials that compared the analgesic effects of different ultrasound-guided quadratus lumborum block approaches in elective caesarean section will be included. Only publications in English will be eligible for inclusion. The total postoperative analgesic consumption over 24 hours will be the primary outcome. The time to first analgesic request, postoperative pain scores at rest and during movement, and incidence of adverse effects will be secondary outcomes. RevMan V.5.4 will be used for the statistical analysis. Network meta-analysis will be used for indirect comparisons between different approaches across studies. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to assess the quality of evidence for each outcome.
    BACKGROUND: Ethical approval was not required. The results of this study will be submitted to peer-reviewed journals.
    UNASSIGNED: CRD42024503694.
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  • 文章类型: Journal Article
    背景:股神经阻滞(FNB)是一种用于膝关节手术后疼痛管理的普遍方法;然而,它降低了股四头肌的力量,不利于手术后的早期恢复。Pectinus肌平面(PMP)阻滞涉及将局部麻醉剂注射到果胶肌下方的筋膜平面中,它阻塞了闭孔和隐神经。然而,关于PMP阻滞用于膝关节手术后镇痛的有效性的证据很少。这项试验的目的是评估PMP阻滞是否可以改善术后镇痛,促进早日康复,减少住院时间。
    方法:在这项随机对照研究中,将46例患者随机分为两组:PMP阻滞组(n=23)和FNB组(n=23)。主要结果指标将包括膝关节手术后各个时间点休息和运动过程中疼痛的视觉模拟量表评分。次要结果将包括主动屈曲的程度,直腿提升测试性能,离床试验结果,20m步行测试结果,通过患者自控镇痛输液泵给予的总剂量,住院时间,患者满意度和术后并发症,如肺栓塞和深静脉血栓形成。本研究方案遵循严格的道德行为和患者安全标准。该试验的结果有望为优化术后疼痛管理策略和改善接受膝关节手术的患者的早期恢复结果提供有价值的见解。
    背景:本试验已于2022年11月17日获得浙江医院伦理委员会(2022(128K))的批准,符合纳入标准和诊断要求的住院患者可以参加本研究。任何后续方案和知情同意文件的修订必须得到负责的伦理委员会的批准。必须记录与监管机构和道德委员会的所有沟通。在随机化之前,所有招募的患者将被告知试验目的和他们在试验中的职责。招募的患者可以随时退出研究,无需提供任何具体原因。患者数据将存储在一个单独的,安全的地方,但它可能会由相关研究者审查。研究结果将发表在国际同行评审的医学期刊上。
    背景:http://www.chictr.org.cn,ID:ChiCTR2300076018。2023年9月21日注册。
    BACKGROUND: Femoral nerve block (FNB) is a prevalent method used for postoperative pain management after knee surgery; however, it decreases the strength of the quadriceps muscle and is not conducive to early recovery after surgery. Pectineus muscle plane (PMP) block involves the injection of a local anaesthetic into the fascial plane below the pectineus muscle, where it blocks the obturator and saphenous nerves. However, there is little evidence on the effectiveness of PMP block for analgesia after knee surgery. The aim of this trial is to assess whether PMP block can improve postoperative analgesia, promote early recovery and reduce the length of hospital stay.
    METHODS: In this randomised controlled study, 46 patients will be randomly allocated into two groups: the PMP block group (n=23) and the FNB group (n=23). The primary outcome measures will include Visual Analog Scale scores for pain at rest and during movement at various time points following knee surgery. Secondary outcomes will include the degree of active flexion, straight leg raise test performance, get-out-of-bed test result, 20 m walk test result, total dose administered via patient-controlled analgesia infusion pumps, hospital stay duration, patient satisfaction and postoperative complications, such as pulmonary embolism and deep vein thrombosis.This study protocol adheres to rigorous standards for ethical conduct and patient safety. The findings from this trial are expected to contribute valuable insights to the optimisation of postoperative pain management strategies and the improvement of early recovery outcomes for patients who undergo knee surgery.
    BACKGROUND: This trial has been approved by the ethics committee of Zhejiang Hospital (2022(128K)) on 17 November 2022, and inpatients who meet the inclusion criteria and diagnostic requirements are eligible for this study. Any subsequent protocol and informed consent document amendments must be approved by the responsible ethics committee. All communications with the regulatory authorities and the ethics committee must be recorded. All recruited patients will be informed of the trial purposes and their duties within the trial before randomisation. Recruited patients can withdraw from the study at any time without providing any specific reason. The patient data will be stored in a separate, safe place, but that it may be reviewed by the relevant investigator. The results will be published in international peer-reviewed medical journals.
    BACKGROUND: http://www.chictr.org.cn, ID: ChiCTR2300076018. Registered on 21 September 2023.
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  • 文章类型: Journal Article
    背景:接受腹腔镜减肥手术(LBS)的肥胖患者经常遇到与阿片类药物麻醉(OBA)或无阿片类药物麻醉(OFA)相关的围手术期不良事件。虽然改良的阿片类药物保留麻醉(MOSA)已被证明可以降低与OBA和OFA相关的不良事件的发生率。这项研究旨在评估MOSA在提高接受LBS的个体恢复质量方面的功效。
    方法:单中心,prospective,双盲,随机对照试验在三级医院进行.将招募并随机分配参加选修LBS的74名合格参与者。MOSA组的患者将接受低剂量阿片类药物的组合,少量右美托咪定,艾氯胺酮和利多卡因,而OBA组将接受标准的阿片类药物全身麻醉。两组患者都将接受标准的围手术期护理。主要结果是在手术后24小时评估的恢复质量-15评分。次要结果包括疼痛水平,焦虑和抑郁评估,胃肠功能恢复,围手术期并发症发生率,阿片类药物的消耗和住院时间。
    背景:昆明市延安医院伦理委员会已提供伦理批准(批准号:2023-240-01)。符合条件的患者将向研究者提供书面知情同意书。该试验的结果将在同行评审的学术期刊上传播。
    背景:研究协议在https://www注册。chictr.org.cn/2023年12月19日。(标识符:ChiCTR2300078806)。该试验使用V.1.0进行。
    BACKGROUND: Obesity patients undergoing laparoscopic bariatric surgery (LBS) are frequently encountered perioperative adverse events related to opioids-based anaesthesia (OBA) or opioids-free anaesthesia (OFA). While modified opioid-sparing anaesthesia (MOSA) has been shown to lower the occurrence of adverse events related to OBA and OFA. This study is to assess the efficacy of MOSA in enhancing the recovery quality among individuals undergoing LBS.
    METHODS: A single-centre, prospective, double-blind, randomised controlled trial is conducted at a tertiary hospital. A total of 74 eligible participants undergoing elective LBS will be recruited and randomly allocated. Patients in the MOSA group will receive a combination of low-dose opioids, minimal dexmedetomidine, esketamine and lidocaine, while in the OBA group will receive standard general anaesthesia with opioids. Patients in both groups will receive standard perioperative care. The primary outcome is the quality of recovery-15 score assessed at 24 hours after surgery. Secondary outcomes include pain levels, anxiety and depression assessments, gastrointestinal function recovery, perioperative complication rates, opioid consumption and length of hospital stay.
    BACKGROUND: Ethical approval has been provided by the Ethical Committee of Yan\'an Hospital of Kunming City (approval No. 2023-240-01). Eligible patients will provide written informed consent to the investigator. The outcomes of this trial will be disseminated in a peer-reviewed scholarly journal.
    BACKGROUND: The study protocol is registered at https://www.chictr.org.cn/ on 19 December 2023. (identifier: ChiCTR2300078806). The trial was conducted using V.1.0.
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  • 文章类型: Journal Article
    目的:本研究旨在比较患者静脉自控镇痛(PCIA)在有和没有低基础输注的情况下对术后低氧血症的影响。
    方法:一项随机平行组非劣效性试验。
    方法:该试验于2021年12月至2022年8月在三级甲等医院进行。
    方法:160名接受胃肠道肿瘤手术并接受术后PCIA的成人。
    方法:参与者在术后48小时随机接受低基础(0.1mg/小时氢吗啡酮)或无基础输注PCIA。
    方法:主要结果是低氧血症的曲线下面积(AUC)每小时,定义为脉搏氧饱和度(SpO2)<95%。次要结果包括:SpO2<90%和<85%时的每小时AUC,氢吗啡酮的消耗,手术后48小时内的下床活动时间和镇痛结果。
    结果:在160名随机患者中,159完成了审判。意向治疗分析显示,与无基础输注组相比,低基础输注组的每小时AUC(SpO2<95%)更大,中位数差异为0.097(95%CI0.001至0.245)。由于两组之间的ROM为2.146(95%CI2.138至2.155),因此未确认非劣效性(边缘:均值比率(ROM)为1.25)。低基础组的氢吗啡酮消耗量高于非基础组(中位数:5.2mg对1.6mg,p<0.001)。同时,其他两个低氧血症阈值的AUC值没有差异,在步行时间,或组间疼痛评分。
    结论:在胃肠道肿瘤切除术后接受氢吗啡酮PCIA的患者中,对于术后低氧血症,SpO2<95%时长达术后48小时,低基础输注的PCIA不如无基础输注.
    背景:ChiCTR2100054317。
    OBJECTIVE: This study aimed to compare the effects of patient-controlled intravenous analgesia (PCIA) with and without low-basal infusion on postoperative hypoxaemia.
    METHODS: A randomised parallel-group non-inferiority trial.
    METHODS: The trial was conducted at a grade-A tertiary hospital from December 2021 to August 2022.
    METHODS: 160 adults undergoing gastrointestinal tumour surgery and receiving postoperative PCIA.
    METHODS: Participants randomly received a low-basal (0.1 mg/hour of hydromorphone) or no-basal infusion PCIA for postoperative 48 hours.
    METHODS: Primary outcome was area under curve (AUC) per hour for hypoxaemia, defined as pulse oxygen saturation (SpO2) <95%. Secondary outcomes included: AUC per hour at SpO2<90% and <85%, hydromorphone consumption, ambulation time and analgesic outcomes up to 48 hours after surgery.
    RESULTS: Among 160 randomised patients, 159 completed the trial. An intention-to-treat analysis showed that AUC per hour (SpO2<95%) was greater in the low-basal infusion group compared with the no-basal infusion group, with a median difference of 0.097 (95% CI 0.001 to 0.245). Non-inferiority (margin: ratio of means (ROM) of 1.25) was not confirmed since the ROM between the two groups was 2.146 (95% CI 2.138 to 2.155). Hydromorphone consumption was higher in the low-basal group than in the no-basal group (median: 5.2 mg versus 1.6 mg, p<0.001). Meanwhile, there were no differences in the AUC values at the other two hypoxaemia thresholds, in ambulation time, or pain scores between the groups.
    CONCLUSIONS: Among the patients receiving hydromorphone PCIA after gastrointestinal tumour resection, low-basal infusion was inferior to no-basal infusion PCIA for postoperative hypoxaemia at SpO2<95% up to 48 hours after surgery.
    BACKGROUND: ChiCTR2100054317.
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  • 文章类型: Systematic Review
    背景:右美托咪定越来越多地用于需要全身麻醉的手术患者。然而,其对以患者为中心的结局的有效性仍不确定.我们的主要目的是评估术中右美托咪定对全身麻醉下需要手术的成年患者的以患者为中心的有效性。
    方法:我们对MEDLINE进行了系统搜索,Embase,中部,WebofScience,和CINAHL从成立到2023年10月。随机对照试验(RCT)比较术中使用右美托咪定与安慰剂,阿片类药物包括在全身麻醉下需要手术的成年患者的常规护理。研究选择,数据提取,偏倚风险评估由两名评审员独立进行.我们使用随机效应贝叶斯回归框架合成数据,以得出效应估计和临床重要效应的概率。对于连续的结果,我们使用标准化平均差(SMD)汇集了具有相似结构的仪器,并在适当时将SMD和可信区间(CrIs)转换为原始量表.我们使用建议分级评估来评估证据的确定性,开发和评估(等级)方法。我们的主要结果是手术后的恢复质量。为了指导原始尺度的解释,使用回收质量-15(QoR-15)仪器(范围0-150点,6分的最小重要差异[MID])。
    结果:我们确定了49,069条引文,纳入5904名参与者的44项RCT符合资格.术中给予右美托咪定与术后QoR-15的改善相关(平均差异9,95%CrI4-14,n=21个随机对照试验,证据的适度确定性)。我们发现任何益处的概率为99%,实现MID的概率为88%。慢性疼痛发生率降低(比值比[OR]0.42,95%CrI0.19-0.79,n=7个随机对照试验,证据的确定性低)。还增加了临床上明显的低血压的风险(OR1.98,95%CrI0.84-3.92,后验伤害概率94%,n=8RCT)和临床显着心动过缓(OR1.74,95%CrI0.93-3.34,后验伤害概率95%,n=10个随机对照试验),两者的证据确定性都很低。告知其他以患者为中心的次要结局的证据有限。
    结论:与安慰剂或标准治疗相比,术中右美托咪定可能导致术后恢复质量和慢性疼痛的显著改善.然而,它可能增加临床上重要的心动过缓和低血压。
    PROSPERO(CRD42023439896)。
    BACKGROUND: Dexmedetomidine is increasingly used for surgical patients requiring general anaesthesia. However, its effectiveness on patient-centred outcomes remains uncertain. Our main objective was to evaluate the patient-centred effectiveness of intraoperative dexmedetomidine for adult patients requiring surgery under general anaesthesia.
    METHODS: We conducted a systematic search of MEDLINE, Embase, CENTRAL, Web of Science, and CINAHL from inception to October 2023. Randomised controlled trials (RCTs) comparing intraoperative use of dexmedetomidine with placebo, opioid, or usual care in adult patients requiring surgery under general anaesthesia were included. Study selection, data extraction, and risk of bias assessment were performed by two reviewers independently. We synthesised data using a random-effects Bayesian regression framework to derive effect estimates and the probability of a clinically important effect. For continuous outcomes, we pooled instruments with similar constructs using standardised mean differences (SMDs) and converted SMDs and credible intervals (CrIs) to their original scale when appropriate. We assessed the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Our primary outcome was quality of recovery after surgery. To guide interpretation on the original scale, the Quality of Recovery-15 (QoR-15) instrument was used (range 0-150 points, minimally important difference [MID] of 6 points).
    RESULTS: We identified 49,069 citations, from which 44 RCTs involving 5904 participants were eligible. Intraoperative dexmedetomidine administration was associated with improvement in postoperative QoR-15 (mean difference 9, 95% CrI 4-14, n=21 RCTs, moderate certainty of evidence). We found 99% probability of any benefit and 88% probability of achieving the MID. There was a reduction in chronic pain incidence (odds ratio [OR] 0.42, 95% CrI 0.19-0.79, n=7 RCTs, low certainty of evidence). There was also increased risk of clinically significant hypotension (OR 1.98, 95% CrI 0.84-3.92, posterior probability of harm 94%, n=8 RCTs) and clinically significant bradycardia (OR 1.74, 95% CrI 0.93-3.34, posterior probability of harm 95%, n=10 RCTs), with very low certainty of evidence for both. There was limited evidence to inform other secondary patient-centred outcomes.
    CONCLUSIONS: Compared with placebo or standard of care, intraoperative dexmedetomidine likely results in meaningful improvement in the quality of recovery and chronic pain after surgery. However, it might increase clinically important bradycardia and hypotension.
    UNASSIGNED: PROSPERO (CRD42023439896).
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  • 文章类型: Journal Article
    背景:Diamedica引气蒸发器2(DDV2)是英国国防医疗服务部门使用的七氟醚蒸发器,用于提供部署的挥发性全身麻醉。防御麻醉系统采用带有涡轮驱动呼吸机的DDV2作为“推倒”蒸发器,从制造商的设计修改。我们调查了七氟醚在不同分钟体积(MV)下的输送,蒸发器设置和温度在这个配置。
    方法:一系列DDV2设置(1%,2%,3%,4%和诱导)和MV(2、4、6和8L/min,每分钟12次通风)在两个环境温度(20和30±3°C)下进行了30分钟的测试。一个补充实验,模拟损伤控制手术期间的麻醉,也完成了,其中DDV2设定为2%,MV为6L/min,持续90分钟。
    结果:在两个实验中,观察到七氟烷递送的两个不同阶段,一个“清洗阶段”,后跟一个“维护期”。洗入阶段通常持续少于5分钟。在维护期间,在低MV和蒸发器设置DDV2提供了一个恒定的输出,而在更高的MV和设置下,蒸汽产量可预见地下降。在20±3°C时,使用临床实践中可能遇到的DDV2设置,七氟醚给药在设定的20%以内.更高的蒸发器设置,MV和温度导致蒸发器设置和试剂输送之间的较大变化。这种变化由DDV2的不完全温度补偿来解释。
    结论:DDV2在一系列设置下可预测地发挥作用,MV和温度。防御麻醉配置中的麻醉递送类似于先前在抽出配置中描述的麻醉递送。该设备被发现是可靠和坚固的。这项实验工作支持继续使用防御麻醉系统来提供和培训已部署的全身麻醉。
    BACKGROUND: The Diamedica Draw-over Vaporiser 2 (DDV2) is the sevoflurane vaporiser used by the UK Defence Medical Services to provide deployed volatile general anaesthesia. The Defence Anaesthesia System employs the DDV2 with a turbine-driven ventilator as a \'push-over\' vaporiser, a modification from the manufacturer\'s design. We investigated sevoflurane delivery at varying minute volumes (MVs), vaporiser settings and temperatures in this configuration.
    METHODS: A range of DDV2 settings (1%, 2%, 3%, 4% and induction) and MVs (2, 4, 6 and 8 L/min at 12 ventilations per minute) were tested at two ambient temperatures (20 and 30±3°C) over 30 min. A supplemental experiment, simulating anaesthesia during damage control surgery, was also completed, where he DDV2 was set to 2% with a 6 L/min MV for 90 min.
    RESULTS: In both experiments, two distinct phases of sevoflurane delivery were noted, a \'wash-in phase\' followed by a \'maintenance period\'. The wash-in phase normally lasted less than 5 min. During the maintenance period at low MVs and vaporiser settings the DDV2 delivered a constant output, while at higher MVs and settings vapour output fell predictably. At 20±3°C, using DDV2 settings likely to be encountered in clinical practice, sevoflurane delivery was within 20% of that set. Higher vaporiser settings, MVs and temperatures resulted in greater variation between vaporiser setting and agent delivery. This variation is explained by the incomplete temperature compensation of the DDV2.
    CONCLUSIONS: The DDV2 functions predictably at a range of settings, MVs and temperatures. Anaesthetic delivery in the defence anaesthesia configuration is like that previously described in the draw-over configuration. The equipment was found to be reliable and robust. This experimental work supports the continued use of the Defence Anaesthesia System for the delivery of and training in deployed general anaesthesia.
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  • 文章类型: Clinical Trial Protocol
    背景:术中阿片类药物已经使用了数十年来减少对伤害感受的负面反应。然而,阿片类药物可能有几种,有时很严重,不利影响。心脏手术使患者面临术后并发症的高风险,其中一些是常见的阿片类药物引起的:急性呼吸衰竭,术后认知功能障碍,术后肠梗阻(POI)或死亡。无阿片类药物麻醉(OFA)策略,基于右美托咪定和利多卡因的使用,可以限制这些不利影响,但是关于这个问题的随机试验尚未在心脏手术中发表。我们假设OFA与基于阿片类药物的麻醉(OBA)可以降低心脏手术后主要阿片类药物相关并发症的发生率。
    方法:多中心,随机化,法国四个心脏外科中心的平行和单盲临床试验,包括268例计划在心脏搭桥术下进行冠状动脉搭桥术的患者,有或没有主动脉瓣置换术。患者将被随机分配到使用瑞芬太尼的对照OBA方案或使用右美托咪定/利多卡因的OFA方案。主要复合终点是以下至少一种情况的发生:(1)通过重症监护病房测试的混乱评估方法评估的术后认知障碍,(2)POI,(3)急性呼吸窘迫或(4)术后前48小时内死亡。次要终点是术后疼痛,吗啡消耗,恶心呕吐,震惊,急性肾损伤,房室传导阻滞,肺炎和住院时间。
    背景:该试验已获得独立的伦理委员会(2021年2月23日保护委员会)的批准。结果将在国际期刊上提交给同行评审。
    背景:NCT04940689,EudraCT2020-002126-90。
    BACKGROUND: Intraoperative opioids have been used for decades to reduce negative responses to nociception. However, opioids may have several, and sometimes serious, adverse effects. Cardiac surgery exposes patients to a high risk of postoperative complications, some of which are common to those caused by opioids: acute respiratory failure, postoperative cognitive dysfunction, postoperative ileus (POI) or death. An opioid-free anaesthesia (OFA) strategy, based on the use of dexmedetomidine and lidocaine, may limit these adverse effects, but no randomised trials on this issue have been published in cardiac surgery.We hypothesised that OFA versus opioid-based anaesthesia (OBA) may reduce the incidence of major opioid-related complications after cardiac surgery.
    METHODS: Multicentre, randomised, parallel and single-blinded clinical trial in four cardiac surgical centres in France, including 268 patients scheduled for coronary artery bypass grafting under cardiac bypass, with or without aortic valve replacement. Patients will be randomised to either a control OBA protocol using remifentanil or an OFA protocol using dexmedetomidine/lidocaine. The primary composite endpoint is the occurrence of at least one of the following: (1) postoperative cognitive disorder evaluated by the Confusion Assessment Method for the Intensive Care Unit test, (2) POI, (3) acute respiratory distress or (4) death within the first 48 postoperative hours. Secondary endpoints are postoperative pain, morphine consumption, nausea-vomiting, shock, acute kidney injury, atrioventricular block, pneumonia and length of hospital stay.
    BACKGROUND: This trial has been approved by an independent ethics committee (Comité de Protection des Personnes Ouest III-Angers on 23 February 2021). Results will be submitted in international journals for peer reviewing.
    BACKGROUND: NCT04940689, EudraCT 2020-002126-90.
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  • 文章类型: Clinical Trial Protocol
    背景:氨甲环酸(TXA)是一种廉价且广泛可用的药物,可减少心脏和骨科手术中的失血和红细胞(RBC)输血。虽然在这些手术中使用TXA是常规的,其在其他手术中的有效性和安全性,包括肿瘤手术,具有可比性的输血率是不确定的。我们的主要目标是评估在接受大型非心脏手术的患者中实施常规TXA的医院政策是否可以减少RBC的输血而不增加血栓形成的风险。
    方法:务实,基于注册表,失明,加拿大10个地点的集群交叉随机对照试验,接受非心脏手术高危红细胞输血的患者。站点以4周的间隔随机分配到术中TXA或匹配安慰剂的医院政策。TXA在皮肤切口处给予1克,然后在皮肤闭合前再加入1克。共同的主要结果是(1)有效性,评估为住院期间输注红细胞的患者比例和(2)安全性,评估90天内诊断为静脉血栓栓塞症的患者比例。次要结果包括:(1)输血:输血的红细胞单位数量(在医院和患者层面);(2)安全性:在医院诊断心肌梗塞,中风,深静脉血栓形成或肺栓塞;(3)临床:住院时间,重症监护室入院,医院生存,90天存活和存活和出院至第30天的天数;和(4)依从性:接受最少一剂研究干预的登记患者的比例。
    背景:已在所有站点获得机构研究伦理委员会的批准。审判结束时,结果的简单语言摘要将发布在试验网站上,并在非专业媒体上分发。我们的试验结果将发表在同行评审的科学杂志上。
    背景:NCT04803747。
    BACKGROUND: Tranexamic acid (TXA) is an inexpensive and widely available medication that reduces blood loss and red blood cell (RBC) transfusion in cardiac and orthopaedic surgeries. While the use of TXA in these surgeries is routine, its efficacy and safety in other surgeries, including oncologic surgeries, with comparable rates of transfusion are uncertain. Our primary objective is to evaluate whether a hospital-level policy implementation of routine TXA use in patients undergoing major non-cardiac surgery reduces RBC transfusion without increasing thrombotic risk.
    METHODS: A pragmatic, registry-based, blinded, cluster-crossover randomised controlled trial at 10 Canadian sites, enrolling patients undergoing non-cardiac surgeries at high risk for RBC transfusion. Sites are randomised in 4-week intervals to a hospital policy of intraoperative TXA or matching placebo. TXA is administered as 1 g at skin incision, followed by an additional 1 g prior to skin closure. Coprimary outcomes are (1) effectiveness, evaluated as the proportion of patients transfused RBCs during hospital admission and (2) safety, evaluated as the proportion of patients diagnosed with venous thromboembolism within 90 days. Secondary outcomes include: (1) transfusion: number of RBC units transfused (both at a hospital and patient level); (2) safety: in-hospital diagnoses of myocardial infarction, stroke, deep vein thrombosis or pulmonary embolism; (3) clinical: hospital length of stay, intensive care unit admission, hospital survival, 90-day survival and the number of days alive and out of hospital to day 30; and (4) compliance: the proportion of enrolled patients who receive a minimum of one dose of the study intervention.
    BACKGROUND: Institutional research ethics board approval has been obtained at all sites. At the completion of the trial, a plain language summary of the results will be posted on the trial website and distributed in the lay press. Our trial results will be published in a peer-reviewed scientific journal.
    BACKGROUND: NCT04803747.
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  • 文章类型: Journal Article
    背景:晚年治疗抵抗型抑郁症(LL-TRD)很常见,会增加加速衰老和认知功能下降的风险。睡眠受损在LL-TRD中很常见,并且是认知能力下降的危险因素。慢波睡眠(SWS)与突触可塑性和记忆等关键过程有关。SWS缺乏可能是抑郁症病理生理学的核心组成部分。麻醉剂异丙酚可以诱导类似于SWS的脑电图(EEG)慢波。丙泊酚可以增强SWS和口服抗抑郁治疗,但是关系不清楚。我们假设丙泊酚输注将增强LL-TRD老年人的SWS并改善抑郁。这一假设得到了最近一个小案例系列的支持。
    方法:SWIPED(异丙酚慢波诱导消除抑郁)第一阶段是一个持续的开放标签,单组试验,评估在LL-TRD老年人中使用异丙酚增强SWS的安全性和可行性。该研究正在招募15名60岁以上的讲英语的成年人使用LL-TRD。参与者将间隔2-6天接受两次异丙酚输注。单独滴定丙泊酚输注以最大化EEG慢波的表达。通过使用配备有干电极的无线头带获取的在家过夜EEG记录来评估输注前和输注后睡眠结构。手动对睡眠EEG记录进行评分。主要的脑电图测量包括睡眠慢波活动,SWS持续时间和delta睡眠比率。抑郁症的纵向变化,评估自杀和快感。在第一次输注之前和第二次输注之后至多10周进行评估。在登记时和第二次输注后约3周评估认知能力。
    背景:这项研究得到了华盛顿大学人类研究保护办公室的批准。2022年11月开始招聘。传播计划包括在科学会议上的演讲,同行评审的出版物和大众媒体。阳性结果将导致更大的II期随机安慰剂对照试验。
    背景:NCT04680910。
    BACKGROUND: Late-life treatment-resistant depression (LL-TRD) is common and increases risk for accelerated ageing and cognitive decline. Impaired sleep is common in LL-TRD and is a risk factor for cognitive decline. Slow wave sleep (SWS) has been implicated in key processes including synaptic plasticity and memory. A deficiency in SWS may be a core component of depression pathophysiology. The anaesthetic propofol can induce electroencephalographic (EEG) slow waves that resemble SWS. Propofol may enhance SWS and oral antidepressant therapy, but relationships are unclear. We hypothesise that propofol infusions will enhance SWS and improve depression in older adults with LL-TRD. This hypothesis has been supported by a recent small case series.
    METHODS: SWIPED (Slow Wave Induction by Propofol to Eliminate Depression) phase I is an ongoing open-label, single-arm trial that assesses the safety and feasibility of using propofol to enhance SWS in older adults with LL-TRD. The study is enrolling 15 English-speaking adults over age 60 with LL-TRD. Participants will receive two propofol infusions 2-6 days apart. Propofol infusions are individually titrated to maximise the expression of EEG slow waves. Preinfusion and postinfusion sleep architecture are evaluated through at-home overnight EEG recordings acquired using a wireless headband equipped with dry electrodes. Sleep EEG recordings are scored manually. Key EEG measures include sleep slow wave activity, SWS duration and delta sleep ratio. Longitudinal changes in depression, suicidality and anhedonia are assessed. Assessments are performed prior to the first infusion and up to 10 weeks after the second infusion. Cognitive ability is assessed at enrolment and approximately 3 weeks after the second infusion.
    BACKGROUND: The study was approved by the Washington University Human Research Protection Office. Recruitment began in November 2022. Dissemination plans include presentations at scientific conferences, peer-reviewed publications and mass media. Positive results will lead to a larger phase II randomised placebo-controlled trial.
    BACKGROUND: NCT04680910.
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  • 文章类型: Journal Article
    背景:胸膜外全肺切除术(EPP)和扩展胸膜切除术/去皮切除术(ePD)是外科细胞减灭术,旨在实现诸如胸膜间皮瘤等恶性胸膜肿瘤的宏观切除,非间皮瘤胸膜恶性肿瘤如胸腺瘤和肉瘤,很少有胸膜结核,以更有限的方式。尽管对手术技术和后果进行了广泛的研究,关于如何最好地应对EPP和ePD的围手术期麻醉挑战,仍然存在显著的知识差距.尚不清楚此类手术的风险分层过程是否标准化,或术前采用哪种类型的功能和动态心脏和肺部检查来协助围手术期风险分层。Further,目前尚不清楚所采用的麻醉和镇痛技术的类型,以及使用的血流动力学监测工具的类型,对结果的影响。还不清楚是否使用个性化的血液动力学方案来指导合理使用液体,血管活性药物和抗张剂。最后,缺乏关于如何在术后最好地监测这些患者的证据,或者最有效的强化恢复方案是什么,以最好地减轻术后并发症和加速出院.为了增加我们对EPP/ePD患者的围手术期和麻醉治疗的认识,本范围审查试图综合文献并确定这些知识差距。
    方法:本范围审查将根据系统审查的首选报告项目和范围审查方案的Meta分析扩展方法进行。电子数据库,OVIDMedline,EMBASE和Cochrane图书馆,系统检索EPP或ePD及围手术期或麻醉管理相关文献。将根据围手术期的三个阶段对数据进行描述性分析和总结,并进行组织:术前,临床护理中的术中和术后因素。
    背景:不需要伦理批准。研究结果将通过专业网络传播,科学期刊上的会议演讲和出版物。
    BACKGROUND: Extrapleural pneumonectomy (EPP) and extended pleurectomy/decortication (ePD) are surgical cytoreductive techniques aimed at achieving macroscopic resection in malignant pleural tumours such as pleural mesothelioma, non-mesothelioma pleural malignancies such as thymoma and sarcoma, and rarely for pleural tuberculosis, in a more limited fashion. Despite extensive studies on both surgical techniques and consequences, a significant knowledge gap remains regarding how best to approach the perioperative anaesthesia challenges for EPP and ePD.It is unknown if the risk stratification processes for such surgeries are standardised or what types of functional and dynamic cardiac and pulmonary tests are employed preoperatively to assist in the perioperative risk stratification. Further, it is unknown whether the types of anaesthesia and analgesia techniques employed, and the types of haemodynamic monitoring tools used, impact on outcomes. It is also unknown whether individualised haemodynamic protocols are used to guide the rational use of fluids, vasoactive drugs and inotropes.Finally, there is a dearth of evidence regarding how best to monitor these patients postoperatively or what the most effective enhanced recovery protocols are to best mitigate postoperative complications and accelerate hospital discharge. To increase our knowledge of the perioperative and anaesthetic treatment for patients undergoing EPP/ePD, this scoping review attempts to synthesise the literature and identify these knowledge gaps.
    METHODS: This scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Review Protocols methodology. Electronic databases, OVID Medline, EMBASE and the Cochrane Library, will be systematically searched for relevant literature corresponding to EPP or ePD and perioperative or anaesthetic management. Data will be analysed and summarised descriptively and organised according to the three perioperative stages: preoperative, intraoperative and postoperative factors in clinical care.
    BACKGROUND: Ethics approval was not required. The findings will be disseminated through professional networks, conference presentations and publications in scientific journals.
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