Gastrointestinal endoscopy

胃肠内窥镜检查
  • 文章类型: Journal Article
    目标:双耳节拍,或同时向每只耳朵分别呈现两个相似频率时产生的感知听觉错觉,在各种程序中被用来减少焦虑。不幸的是,在接受上消化道内窥镜检查的患者中,先前没有涉及手术前双耳音乐暴露的研究,这项研究旨在探讨其对接受无镇静上消化道内镜检查的参与者的焦虑和耐受性的影响。方法:前瞻性,控制,随机试验包括96名年龄在18至70岁之间的土耳其患者参与,这些患者计划进行上消化道内窥镜检查,不管性别或疾病,并随机分为两组进行内窥镜检查,即,双耳搏动组(n=48)和对照组(n=48)。双耳节拍音乐组的患者戴着耳机,和音乐是在内窥镜检查前15分钟;然而,两组均未给予特殊治疗.使用状态特质焦虑量表评估焦虑水平,除了内镜检查前后的变化以根据医生记录的医生记录的干咳次数来衡量患者满意度外,还记录并比较了两组之间的耐受性。结果:结果表明,按照此程序,在音乐小组中,状态分数仍然显著低于之前的水平(p=0.016),与对照组比较(p>0.05)。在舒张压、收缩压或心率的变化方面无显著性差异(p>0.05)。然而,音乐组的程序耐受性和满意度得分明显高于无音乐组(p<0.05)。结论:对于接受上消化道内镜检查的患者,音乐与双耳节拍被发现显着降低焦虑水平和增加患者的耐受性,提供镇静药物的替代选择作为潜在的镇静治疗选择。临床试验登记号:NCT06114524。
    Objective: Binaural beats, or the perceptual auditory illusions created when simultaneously presenting two similar frequencies to each ear separately, have been used to reduce anxiety in various procedures. Unfortunately, no prior study involved preprocedure binaural music exposure among patients undergoing upper gastrointestinal endoscopy, and this study sought to investigate its effect on anxiety and tolerance among participants undergoing sedation-free upper gastrointestinal endoscopy. Methods: The prospective, controlled, randomized trial included the participation of 96 Turkish patients aged between 18 and 70 years who were scheduled for an upper gastrointestinal endoscopy, regardless of sex or illness, and were divided randomly into two different groups to undergo endoscopy, namely, the binaural beats group (n = 48) and a control group (n = 48). Patients in the binaural beat music group wore headphones, and music was given 15 mins before endoscopy; however, no particular treatment was given for either group. Anxiety levels were assessed by using the State Trait Anxiety Inventory questionnaire, in addition to changes before and after endoscopy to measure patient satisfaction based on the physician\'s recorded numbers of retches noted by doctors as tolerance was documented and compared among both groups. Results: The results showed that following this procedure, in the music group, state scores remained significantly lower than before them (p = 0.016), compared with the control group (p > 0.05). There was no significant difference regarding changes in diastolic or systolic heart rate or blood pressure (p > 0.05). However, the procedure tolerance and satisfaction scores were significantly higher in the music group than those without music (p < 0.05). Conclusion: For patients undergoing upper gastrointestinal endoscopy, music with binaural beats was found to significantly reduce anxiety levels and increase patient tolerance, providing an alternative option to sedative medications as a potential sedative treatment option.Clinical trials registration number: NCT06114524.
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  • 文章类型: Journal Article
    背景:甲苯磺酸雷马唑仑是目前用于胃肠内窥镜检查的新型苯二氮卓类药物,可与阿芬太尼联合使用。
    目的:本试验比较了瑞马唑仑联合阿芬太尼与异丙酚联合阿芬太尼在胃肠镜检查患者中的有效性和安全性。
    方法:160例患者随机分为丙泊酚-阿芬太尼麻醉(P组)和瑞咪唑安定-阿芬太尼麻醉(R组)。主要结果是围手术期血流动力学变量,包括收缩压(SBP),舒张压(DBP),平均动脉压(MAP),术前(T0)心率(HR)和氧饱和度(SpO2);麻醉诱导后(T1);当胃镜通过口咽时(T2);3分钟(T3),T2后5min(T4)和7min(T5);手术结束时(T6);患者苏醒成功时(T7)。次要结果包括诱导时间和觉醒时间,患者满意度,操作员满意度,和不良事件发生。
    结果:与P组相比,R组T1、T2、T3、T6时SBP明显增高(P<0.05);T1、T2、T3、T5、T6时DBP、MAP明显增高(P<0.05);T1~T6时HR明显加快(P<0.05);T1~T4时SpO2明显增高(P<0.05);低血压,药物注射痛明显低于R组(P<0.05);打嗝发生率高于R组(P<0.05);苏醒时间短于R组(P<0.05);操作者满意度得分高(P<0.05)。
    结论:与异丙酚和阿芬太尼相比,瑞马唑仑联合阿芬太尼可安全有效地用于胃肠镜检查患者的镇静,对患者循环和呼吸系统的影响较小,不良事件发生率较低。
    背景:该试验方案已在中国临床试验注册中心注册(ChiCR2300077252,日期:2023-11-02)。
    BACKGROUND: Remimazolam tosilate is a new type of benzodiazepine currently used for gastrointestinal endoscopy and can be combined with alfentanil.
    OBJECTIVE: This trial compared the effectiveness and safety of remimazolam with alfentanil to propofol with alfentanil in patients undergoing gastrointestinal endoscopy.
    METHODS: One hundred and sixty-six patients were randomly divided into propofol-alfentanil anaesthesia (Group P) and remimazolam-alfentanil anaesthesia (Group R). The primary outcomes were perioperative haemodynamic variables, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR) and oxygen saturation (SpO2) preoperatively (T0); after anaesthesia induction (T1); when the gastroscope passed through the oropharynx (T2); 3 min (T3), 5 min (T4) and 7 min (T5) after T2; at the end of surgery (T6); and when patients successfully awakened (T7). The secondary outcomes included induction and awakening time, patient satisfaction, operator satisfaction, and adverse event occurrences.
    RESULTS: Compared with those in Group P, the SBP in Group R was significantly higher at T1, T2, T3, and T6 (P < 0.05); the DBP and MAP were significantly higher at T1, T2, T3, T5, and T6 (P < 0.05); the HR was significantly faster at T1 to T6 (P < 0.05); the SpO2 was significantly higher at T1 to T4 (P < 0.05); the incidences of hypoxemia, hypotension, and drug injection pain were significantly lower in Group R (P < 0.05); the incidence of hiccups was higher (P < 0.05); the awakening time was shorter in Group R (P < 0.05); and the operator satisfaction score was high (P < 0.05).
    CONCLUSIONS: Compared to propofol with alfentanil, remimazolam with alfentanil can be used safely and effectively for sedation in patients undergoing gastrointestinal endoscopy, with less impact on the patient\'s circulatory and respiratory systems and a lower incidence of adverse events.
    BACKGROUND: This trial protocol was registered in the Chinese Clinical Trial Registry (ChiCR2300077252, date: 2023-11-02).
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  • 文章类型: Journal Article
    雷马唑仑是一种新型的短效苯二氮卓类药物,用于镇静和全身麻醉。本研究旨在评估在接受诊断性胃肠镜检查的老年患者中使用苯磺酸瑞咪唑安定的有效性和安全性。
    将120名年龄在60-75岁的患者随机分为两组。采用瑞芬太尼0.3μg/kg镇痛。患者分别给予苯磺酸瑞米唑仑7mg(R组)或依托咪酯0.1mg/kg联合1%丙泊酚0.5mg/kg(EP组)进行诱导,根据需要给予补充重复剂量。一些时间指标,生命体征,对不良事件进行了评估.比较患者的Mini-cog评分和康复问卷。
    与EP组相比,R组诱导时间稍长(1.50VS1.15分钟)(P<0.05),在麻醉后监护病房(PACU)中花费的时间较短(15.17VS17.40分钟)(P<0.05)。与EP组相比,在T15和T25时间点,R组SBP较低,T2、T3、T5时心率较高(P<0.05)。术后Mini-Cog评分较高(2.83VS2.58)(P<0.05)。EP组呼吸不良事件发生率高于R组(18.3%VS5.0%,P<0.05)。R组最常见的不良事件是打嗝。R组患者的镇静满意率和健忘症程度均较高(66.7%VS11.7%)(P<0.05),对患者24小时内生活的影响较低(12.0%VS30.5%)(P<0.05)。
    苯磺酸瑞马唑仑的安全性和有效性不亚于依托咪酯联合丙泊酚,使其成为ASAI-II老年患者在胃肠内窥镜检查期间镇静的安全选择,但是应该注意监控打嗝的发生。
    UNASSIGNED: Remimazolam is a novel short-acting benzodiazepine used for sedation and general anesthesia. This study aimed to evaluate the efficacy and safety of remimazolam besylate in elderly patients who underwent diagnostic gastrointestinal endoscopy.
    UNASSIGNED: A total of 120 patients aged 60-75 years were randomly allocated to one of two groups. Remifentanil 0.3μg/kg was used for analgesia. Patients were administered remimazolam besylate 7 mg (R group) or etomidate 0.1 mg/kg combined with 1% propofol 0.5 mg/kg (EP group) for induction, supplemental repeated doses were given as needed. Some time metrics, vital signs, adverse events were evaluated. Patients\' Mini-cog score and recovery questionnaires were compared.
    UNASSIGNED: Compared to the EP group, the induction time was slightly longer in the R group (1.50 VS 1.15 minutes) (P<0.05), the time spent in the post-anesthesia care unit (PACU) was shorter (15.17 VS 17.40 minutes) (P<0.05). Compare with EP group, SBP was lower in R group at T15 and T25 time point, but heart rate was higher in T2, T3, T5 (P< 0.05). The Mini-Cog score was higher after the procedure (2.83 VS 2.58) (P<0.05). The incidence of respiratory adverse events was higher in the EP group than R group (18.3% VS 5.0%, P < 0.05). The most common adverse event in R group was hiccups. The sedation satisfaction rate and degree of amnesia were higher in the R group (66.7% VS 11.7%) (P < 0.05), and the effect on patient\'s life within 24 hours was lower (12.0% VS 30.5%) (P < 0.05).
    UNASSIGNED: The safety and efficacy of remimazolam besylate are not inferior to those of etomidate combined with propofol, rendering it a safe option for sedation during gastrointestinal endoscopy in ASA I-II elderly patients, but care should be taken to monitor the occurrence of hiccups.
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  • 文章类型: Journal Article
    背景:需要进一步的临床验证,以确定经皮穴位电刺激(TEAS)是否可以替代阿片类药物,并与瑞马唑仑联合用于胃肠内窥镜检查期间的镇静作用。
    方法:将108例行诊断性胃肠内镜检查的门诊患者随机分为3组:芬太尼加瑞马唑仑组(C组),TEAS加瑞米唑仑组(E组),和安慰剂-TEAS加瑞马唑仑组(P组)。对患者满意度的评估,医生满意度,检查过程中的疼痛评分构成了研究的主要终点。次要终点是恢复时间,恢复正常的行为功能和出院,不良反应发生率,和剂量的雷米唑仑。
    结果:与C组相比,E组随访时患者满意度中位数得分较高,而医师满意度中位数得分略低.E组疼痛评分略大于C组,但差异不显著。然而,C组,低氧血症的发生率,恶心的发生率和眩晕的严重程度更大,出院和恢复正常行为功能的人数多于其他两组。C组和E组患者的瑞马唑仑剂量明显少于P组。
    结论:TEAS联合适度的瑞马唑仑镇静可提供理想的镇静效果。其优选地抑制由胃肠内窥镜检查引起的不适并且具有较少的镇静相关并发症。
    背景:ID:NCT05485064;首次注册(29/07/2022);最后注册(02/11/2022)(ClinicalTrials.gov)。
    BACKGROUND: Further clinical validation is required to determine whether transcutaneous electrical acupoint stimulation (TEAS) can replace opioids and be used in combination with remimazolam for sedation during gastrointestinal endoscopy.
    METHODS: A total of 108 outpatients who underwent diagnostic gastrointestinal endoscopy were randomly divided into three groups: fentanyl plus remimazolam group (group C), TEAS plus remimazolam group (group E), and placebo-TEAS plus remimazolam group (group P). The assessments of patient satisfaction, physician satisfaction, and pain scale score during the examination constituted the primary endpoints of the study. The secondary endpoints were the time of recovery, recovery of normal behavioral function and discharge, incidence of adverse reactions, and dose of remimazolam.
    RESULTS: Compared with group C, group E had a greater median score for patient satisfaction at follow-up and a slightly lower median score for physician satisfaction. The pain score of group E was slightly greater than that of group C, but the difference was not significant. However, in group C, the incidence of hypoxemia, the rate of nausea and the severity of vertigo were greater, and the number of patients discharged and resuming normal behavioral function was greater than those in the other two groups. The dose of remimazolam in group C and group E was less than that in group P.
    CONCLUSIONS: TEAS combined with moderate sedation of remimazolam can provide an ideal sedative effect, which preferably suppresses discomfort caused by gastrointestinal endoscopy and has fewer sedation-related complications.
    BACKGROUND: ID: NCT05485064; First registration (29/07/2022); Last registration (02/11/2022) (Clinical Trials.gov).
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  • 文章类型: Journal Article
    目的:很少有研究通过纹理和彩色增强成像(TXI)评估结肠镜检查的腺瘤检出率(ADR),一种新颖的图像增强技术。这项研究比较了使用TXI和使用白光成像(WLI)检测结直肠息肉。
    方法:此单中心回顾性研究使用基于患者基线特征的倾向匹配评分(年龄,性别,指示,肠道准备,内窥镜医师,结肠镜类型,和停药时间),以比较在丰岛内窥镜检查诊所使用WLI或TXI进行色素内窥镜检查的患者的结果。确定TXI组和WLI组之间的息肉检出率和每次结肠镜检查检测到的息肉平均数量的差异。
    结果:在倾向得分匹配后,1970例患者被纳入每个成像模式组。患者平均年龄为57.2±12.5岁,其中44.5%为男性.TXI组的ADR高于WLI组(55.0%vs49.4%,赔率比:1.25)。TXI组比WLI组更常见高危ADR(17.6%vs12.8%;OR:1.45)。TXI组每次结肠镜检查(APC)的平均腺瘤数量高于WLI组(1.187vs0.943,OR:1.12)。与WLI组相比,TXI组形态平坦的APC(1.093vs0.848,OR:1.14)和<6mm的APC(0.992vs0.757,OR:1.16)较高。
    结论:与WLI相比,根据实际临床数据,TXI改善了行色素内镜检查的患者的ADR。
    OBJECTIVE: Few studies have evaluated the adenoma detection rate (ADR) of colonoscopy with texture and color enhancement imaging (TXI), a novel image-enhancing technology. This study compares the detection of colorectal polyps using TXI to that using white light imaging (WLI).
    METHODS: This single-center retrospective study used propensity-matched scoring based on the patients\' baseline characteristics (age, sex, indication, bowel preparation, endoscopist, colonoscope type, and withdrawal time) to compare the results of patients who underwent chromoendoscopy using WLI or TXI at the Toyoshima Endoscopy Clinic. The differences in polyp detection rates and the mean number of detected polyps per colonoscopy were determined between the TXI and WLI groups.
    RESULTS: After propensity score matching, 1970 patients were enrolled into each imaging modality group. The mean patient age was 57.2 ± 12.5 years, and 44.5% of the cohort were men. The ADR was higher in the TXI group than in the WLI group (55.0% vs 49.4%, odds ratio: 1.25). High-risk ADR were more common in the TXI group than in the WLI group (17.6% vs 12.8%; OR: 1.45). The mean number of adenomas per colonoscopy (APC) was higher in the TXI group than in the WLI group (1.187 vs 0.943, OR: 1.12). APC with a flat morphology (1.093 vs 0.848, OR: 1.14) and APC of <6 mm (0.992 vs 0.757, OR: 1.16) were higher in the TXI group than in the WLI group.
    CONCLUSIONS: Compared to WLI, TXI improved the ADR in patients who underwent chromoendoscopy based on actual clinical data.
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  • 文章类型: Systematic Review
    艾氯胺酮在小儿胃肠内镜检查中的作用尚不清楚。本研究旨在评估艾氯胺酮用于小儿胃肠内镜检查的有效性和安全性。
    在八个常见数据库中搜索了用于小儿胃肠镜检查的艾氯胺酮临床试验,到2023年10月。这些临床试验包括在荟萃分析和试验序贯分析(TSA)中。使用风险比(RR)和加权平均差(WMD)作为二分变量和连续性变量的效应大小,分别。当异质性测试显示I2<50%时,固定效应模型用于荟萃分析和TSA;否则,随机效应模型被用于他们。
    就疗效终点而言,荟萃分析表明,与安慰剂或空白相比,艾氯胺酮显著缩短恢复时间2.34分钟(WMD-2.34;95%置信区间[CI]-3.65,-1.02;p=0.0005)和丙泊酚消耗量0.70mg/kg(WMD-0.70;95%CI-0.98,-0.43;p<0.00001),平均心率增加4.77次/分(WMD4.77;95%CI2.67,6.87;p<0.00001),平均动脉压增加3.10mmHg(WMD3.10;95%CI1.52,4.67;p=0.0001),而诱导时间和平均血氧保持相当。TSA指出了这些益处的确凿证据。就安全终点而言,荟萃分析显示,艾氯胺酮显著减少了59%的不自主运动(RR0.41;95%CI0.22,0.76;p=0.005)和51%的窒息(RR0.49;95%CI0.26,0.92;p=0.03),而头晕显著增加98%(RR1.98;95%CI1.11,3.56;p=0.02),总不良事件无显著差异,呼吸抑制,和呕吐。TSA证明了不自主运动和头晕的确凿证据。低剂量分析表明,≤0.3mg/kg的艾氯胺酮可显著缩短恢复时间,异丙酚消耗和不自主运动,显著增加平均心率,没有增加头晕。Begg检验(p=0.327)和Egger检验(p=0.413)没有明显的发表偏倚,然而漏斗图提示潜在的发表偏倚.
    Esketamine是接受胃肠内窥镜检查的儿童的有效辅助麻醉。然而,一般剂量的艾氯胺酮可能会增加头晕的风险,这可以通过施用低剂量(≤0.3mg/kg)来避免。
    UNASSIGNED: The role of esketamine in pediatric gastrointestinal endoscopy is still unclear. This study aims to evaluate the efficacy and safety of esketamine for pediatric gastrointestinal endoscopy.
    UNASSIGNED: Clinical trials of esketamine for pediatric gastrointestinal endoscopy were searched in eight common databases, up to October 2023. These clinical trials were included in the meta-analysis and trial sequential analysis (TSA). The risk ratio (RR) and weighted mean difference (WMD) were used as the effect sizes for dichotomous variables and continuity variables, respectively. When the heterogeneity test showed I2 < 50%, the fixed effects model was used for the meta-analysis and TSA; Otherwise, the random effects model was used for them.
    UNASSIGNED: In terms of efficacy endpoints, the meta-analysis showed that compared with placebo or blank, esketamine significantly decreased recovery time by 2.34 min (WMD -2.34; 95% Confidence interval [CI] -3.65, -1.02; p = 0.0005) and propofol consumption by 0.70 mg/kg (WMD -0.70; 95% CI -0.98, -0.43; p < 0.00001), and increased mean heart rate by 4.77 beats/min (WMD 4.77; 95% CI 2.67, 6.87; p < 0.00001) and mean arterial pressure by 3.10 mmHg (WMD 3.10; 95% CI 1.52, 4.67; p = 0.0001), while induction time and mean blood oxygen remained comparable. TSA indicated conclusive evidence for these benefits. In terms of safety endpoints, the meta-analysis revealed that esketamine significantly reduced involuntary movements by 59% (RR 0.41; 95% CI 0.22, 0.76; p = 0.005) and choking by 51% (RR 0.49; 95% CI 0.26, 0.92; p = 0.03), while significantly increasing dizziness by 98% (RR 1.98; 95% CI 1.11, 3.56; p = 0.02) and there were no significant differences in total adverse events, respiratory depression, and vomiting. TSA demonstrated conclusive evidence for involuntary movements and dizziness. Low-dose analysis showed that esketamine at ≤0.3 mg/kg significantly reduced recovery time, propofol consumption and involuntary movements, and significantly increasing mean heart rate, with no increase in dizziness. The Begg\'s test (p = 0.327) and the Egger\'s test (p = 0.413) indicated no significant publication bias, yet the funnel plot suggested potential publication bias.
    UNASSIGNED: Esketamine is an effective adjuvant anesthesia for children undergoing gastrointestinal endoscopy. However, the general dose of esketamine may increase the risk of dizziness, which can be avoided by administering a low dose (≤0.3 mg/kg).
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  • 文章类型: Journal Article
    目的:探讨甲磺酸瑞米唑仑对胃肠镜检查患者胃肠激素及运动功能的影响。
    方法:总共262名美国麻醉医师协会体格状态I或II的患者,18-65岁,计划进行胃肠内窥镜检查并进行镇静,随机分为两组(每组n=131):甲苯磺酸瑞米唑仑组(R组)和异丙酚组(P组)。R组患者静脉内接受0.2-0.25mg/Kg甲苯磺酸瑞咪唑安定,而P组患者静脉注射丙泊酚1.5~2.0mg/kg.当改良观察者的警觉/镇静评估评分≤3时,进行胃肠内镜检查。主要终点包括内镜医师的内镜肠蠕动评分;空腹时无胃肠道准备(T0)的血清胃动素和胃泌素水平,胃肠内镜检查前(T1),以及离开麻醉后护理室(T2)之前;以及麻醉后护理室期间腹胀的发生率。
    结果:与P组相比,R组的肠蠕动评分较高(P<.001);与P组相比,R组T2时胃动素和胃泌素水平升高(P<.01)。两组在T1和T2时胃动素和胃泌素水平均高于T0,在T2时高于T1(P<0.01)。R组腹胀发生率较低(P<0.05)。
    结论:与在胃肠镜检查过程中使用丙泊酚镇静相比,甲苯磺酸瑞米唑仑轻度抑制血清胃动素和胃泌素水平,可能促进胃肠蠕动的恢复。
    OBJECTIVE: To investigate the impacts of remimazolam tosilate on gastrointestinal hormones and motility in patients undergoing gastrointestinal endoscopy with sedation.
    METHODS: A total of 262 American Society of Anesthesiologists Physical Status I or II patients, aged 18-65 years, scheduled for gastrointestinal endoscopy with sedation, were randomly allocated into two groups (n = 131 each): the remimazolam tosilate group (Group R) and the propofol group (Group P). Patients in Group R received 0.2-0.25 mg/Kg remimazolam tosilate intravenously, while those in Group P received 1.5-2.0 mg/kg propofol intravenously. The gastrointestinal endoscopy was performed when the Modified Observer\'s Assessment of Alertness/Sedation scores were ≤3. The primary endpoints included the endoscopic intestinal peristalsis rating by the endoscopist; serum motilin and gastrin levels at fasting without gastrointestinal preparation (T0), before gastrointestinal endoscopy (T1), and before leaving the Post Anesthesia Care Unit (T2); and the incidences of abdominal distension during Post Anesthesia Care Unit.
    RESULTS: Compared with Group P, intestinal peristalsis rating was higher in Group R (P < .001); Group R showed increased motilin and gastrin levels at T2 compared with Group P (P < .01). There was a rise in motilin and gastrin levels at T1 and T2 compared with T0 and at T2 compared with T1 in both groups (P < .01). The incidence of abdominal distension was lower in Group R (P < .05).
    CONCLUSIONS: Compared with propofol used during gastrointestinal endoscopy with sedation, remimazolam tosilate mildly inhibits the serum motilin and gastrin levels, potentially facilitating the recovery of gastrointestinal motility.
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  • 文章类型: Journal Article
    目的:在多中心的内窥镜检查中,评估瑞米唑仑对生理盐水(安慰剂)作为镇静剂的有效性,随机化,双盲,研究者发起的III期对照试验.
    方法:我们纳入了48例接受上消化道内镜检查的日本患者。对于程序,最初的雷米唑仑剂量为3毫克,额外的剂量为1毫克,在II期临床研究中确定。主要研究终点是胃肠镜检查期间的成功镇静率,在开始内窥镜检查之前,确定为改良观察者的警报/镇静评分≤4,完成胃肠内窥镜检查,和两个或更少的额外剂量每6分钟。
    结果:雷米咪唑安定组和安慰剂组的内镜镇静成功率分别为91.9%和9.1%,分别为(P<0.01)。两组从内窥镜检查结束到唤醒的时间为0.0(0.0-0.0)min。雷米马唑仑组实现镇静所需的额外剂量数低于安慰剂组(P<0.01)。
    结论:雷马唑仑在日本患者上消化道内镜检查中显示出明显更高的镇静作用,与安慰剂相比,日本患者具有安全和快速的恢复。
    OBJECTIVE: To assess the effectiveness of remimazolam against normal saline (placebo) as a sedative agent for endoscopy in a multicenter, randomized, double-blind, investigator-initiated phase III controlled trial.
    METHODS: We included 48 Japanese patients undergoing upper gastrointestinal endoscopy. For the procedure, an initial remimazolam dose of 3 mg and additional doses of 1 mg were administered, as determined in the phase II clinical study. The primary study end-point was the successful sedation rate during gastrointestinal endoscopy, determined as a Modified Observer\'s Assessment of Alertness/Sedation score ≤4 before the start of endoscopy, the completion of gastrointestinal endoscopy, and two or fewer additional doses per 6 min.
    RESULTS: The successful endoscopy sedation rates were 91.9% and 9.1% in the remimazolam and placebo groups, respectively (P < 0.01). The time from the end of endoscopy to arousal was 0.0 (0.0-0.0) min for both groups. The number of additional doses required to achieve sedation was lower in the remimazolam group than that in the placebo group (P < 0.01).
    CONCLUSIONS: Remimazolam demonstrated a significantly higher sedation effect during upper gastrointestinal endoscopy in Japanese patients with safe and fast recovery compared with placebo.
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  • 文章类型: Randomized Controlled Trial
    目的:评估一种基于ECG的方法,称为胸阻抗通气图,以减少内窥镜检查中的缺氧事件。
    方法:这是一个单一的中心,1:1随机对照试验。
    方法:该试验在经皮内镜胃造瘘术(PEG)放置期间进行。
    方法:173名接受PEG置入的患者纳入本试验。大多数患者(89%)的适应症是肿瘤学。58%的患者为ASAⅡ级,42%的患者为ASAⅢ级。
    方法:将患者随机分为标准监测组(SM)和脉搏血氧饱和度和自动血压测量组,或在干预组(TIM)增加胸阻抗呼吸图。由胃肠病学家或训练有素的护士用丙泊酚进行镇静。
    方法:缺氧事件定义为SpO2<90%持续>15s是主要终点。次要终点是最小SpO2,呼吸暂停>10s/>30s和发生的成本。
    结果:额外使用胸阻抗呼吸描记术可显著减少缺氧事件(TIM:31%vsSM:49%;p=0.016;OR0.47;NNT5.6),并且每次手术的最低SpO2升高(TIM:90.0%±8.9;SM:84.0%±17.6;p=0.007)。与SM(1%;0%;p<0.001;p=0.014)相比,在TIM中检测到呼吸暂停事件>10s和>30s的频率显著更高(43%;7%),导致在缺氧事件发生前17s的时间优势。因此,与TIM相比,SM患者更需要调整氧气流量(p=0.034),与SM患者(9%;p=0.053)相比,TIM患者更不需要辅助通气(2%).额外使用胸阻抗肺图的计算成本为每次手术0.13美元(0.12欧元/0.11英镑)。
    结论:额外的胸阻抗通气减少了低氧事件的数量和程度,而辅助通气的需求较少。每个程序的补充费用可以忽略不计。
    背景:胸阻抗肺图,二氧化碳描记,镇静,监测,胃肠内窥镜检查,经皮内镜胃造瘘术.
    To assess the efficacy of an ECG-based method called thoracic impedance pneumography to reduce hypoxic events in endoscopy.
    This was a single center, 1:1 randomized controlled trial.
    The trial was conducted during the placement of percutaneous endoscopic gastrostomy (PEG).
    173 patients who underwent PEG placement were enrolled in the present trial. Indication was oncological in most patients (89%). 58% of patients were ASA class II and 42% of patients ASA class III.
    Patients were randomized in the standard monitoring group (SM) with pulse oximetry and automatic blood pressure measurement or in the intervention group with additional thoracic impedance pneumography (TIM). Sedation was performed with propofol by gastroenterologists or trained nurses.
    Hypoxic episodes defined as SpO2 < 90% for >15 s were the primary endpoint. Secondary endpoints were minimal SpO2, apnea >10s/>30s and incurred costs.
    Additional use of thoracic impedance pneumography reduced hypoxic episodes (TIM: 31% vs SM: 49%; p = 0.016; OR 0.47; NNT 5.6) and elevated minimal SpO2 per procedure (TIM: 90.0% ± 8.9; SM: 84.0% ± 17.6; p = 0.007) significantly. Apnea events >10s and > 30s were significantly more often detected in TIM (43%; 7%) compared to SM (1%; 0%; p < 0.001; p = 0.014) resulting in a time advantage of 17 s before the occurrence of hypoxic events. As a result, adjustments of oxygen flow were significantly more often necessary in SM than in TIM (p = 0.034) and assisted ventilation was less often needed in TIM (2%) compared with SM (9%; p = 0.053). Calculated costs for the additional use of thoracic impedance pneumography were 0.13$ (0.12 €/0.11 £) per procedure.
    Additional thoracic impedance pneumography reduced the quantity and extent of hypoxic events with less need of assisted ventilation. Supplemental costs per procedure were negligible.
    thoracic impedance pneumography, capnography, sedation, monitoring, gastrointestinal endoscopy, percutaneous endoscopic gastrostomy.
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  • 文章类型: Journal Article
    目的:已经努力开发一种纳入血清学胃癌(GC)风险分层(ABC分类)以及每年使用钡进行基于人群的GC筛查的内镜筛查系统。我们进行了一项随机对照试验(RCT),以比较Ba-Endo组之间的GC检出率,每年进行钡检查以进行初级筛查,然后进行详细的内窥镜检查,和ABC-Endo集团,其中内窥镜检查间隔是根据ABC分类中的个体胃癌风险确定的。
    方法:总共,来自Yurihonjo和Nikaho市的1,206人,秋田县,通过使用性别和年龄作为分配因素的最小化方法进行随机化。干预研究在5年内对两组进行。Ba-Endo小组每年接受钡检测,ABC-Endo组在不同的间隔时间接受了食管胃十二指肠镜检查(EGD):A组(仅在进入时进行EGD),B(EGD每3年一次),C(EGD每2年一次),和D(每年EGD)。
    结果:共检出24处GC病变,GC检出率为1.9%。Ba-Endo和ABC-Endo组的GC检出率分别为2.0%和1.8%,分别,组间无显著差异(P=1.0)。然而,Ba-Endo组仅通过内镜切除治愈GC的比率为41.6%,而ABC-Endo组为90.9%(P=0.02).
    结论:Ba-Endo组和ABC-Endo组的GC检出率没有差异。然而,在ABC-Endo组中,检测到的仅可通过内镜切除治愈的GCs的比率显著较高.
    OBJECTIVE: Efforts have been made to develop an endoscopic screening system incorporating serologic gastric cancer (GC) risk stratification (ABC classification) alongside annual population-based GC screening using barium. We conducted a randomized controlled trial (RCT) to compare GC detection rates between the Ba-Endo group, which underwent annual barium tests for primary screening followed by detailed endoscopic examinations, and the ABC-Endo group, where endoscopy intervals were determined based on individual gastric cancer risk in the ABC classification.
    METHODS: In total, 1206 individuals from Yurihonjo and Nikaho City, Akita Prefecture, were randomized through the minimization method using sex and age as allocation factors. The intervention study was conducted for both groups over 5 years. The Ba-Endo group received annual barium tests, and the ABC-Endo group underwent EGD at different intervals: group A, EGD only at entry; group B, EGD once every 3 years; group C, EGD once every 2 years; and group D, EGD every year.
    RESULTS: There were 24 detected GC lesions, with a GC detection rate of 1.9%. GC detection rates in the Ba-Endo and ABC-Endo groups were 2.0% and 1.8%, respectively, with no significant differences between groups (P = 1.0). However, the rate of GC cured by endoscopic resection alone was 41.6% in the Ba-Endo group and was significantly higher at 90.9% in the ABC-Endo group (P = .02).
    CONCLUSIONS: There were no differences between the Ba-Endo and ABC-Endo groups in GC detection rates. However, the rate of detected GCs that could be cured by endoscopic resection alone was significantly higher in the ABC-Endo group. (Clinical trial registration number: UMIN000005962.).
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