Vaughan Jessica, Nagendran Myura, Cooper Jacqueline, Davidson Brian R, Gurusamy Kurinchi Selvan
Department of Surgery, Royal Free Campus, UCL Medical School, London, UK, NW3 2QG.
Cochrane Database Syst Rev. 2014 Jan 24;2014(1):CD009784. doi: 10.1002/14651858.CD009784.pub2.
Day surgery involves admission of selected patients to hospital for a planned surgical procedure with the patients returning home on the same day. An anaesthetic regimen usually involves a combination of an anxiolytic, an induction agent, a maintenance agent, a method of maintaining the airway (laryngeal mask versus endotracheal intubation), and a muscle relaxant. The effect of anaesthesia may continue after the completion of surgery and can delay discharge. Various regimens of anaesthesia have been suggested for day-procedure laparoscopic cholecystectomy.
To compare the benefits and harms of different anaesthetic regimens (risks of mortality and morbidity, measures of recovery after surgery) in patients undergoing day-procedure laparoscopic cholecystectomy.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (Issue 10, 2013), MEDLINE (PubMed) (1987 to November 2013), EMBASE (OvidSP) (1987 to November 2013), Science Citation Index Expanded (ISI Web of Knowledge) (1987 to November 2013), LILACS (Virtual Health Library) (1987 to November 2013), metaRegister of Controlled Trials (http://www.controlled-trials.com/mrct/) (November 2013), World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) portal (November 2013), and ClinicalTrials.gov (November 2013).
We included randomized clinical trials comparing different anaesthetic regimens during elective day-procedure laparoscopic cholecystectomy (irrespective of language or publication status).
Two authors independently assessed trials for inclusion and independently extracted the data. We calculated the risk ratio, rate ratio or mean difference with 95% confidence intervals based on intention-to-treat or available data analysis.
We included 11 trials involving 1069 participants at low anaesthetic risk. The sample size varied from 40 to 300 participants. We included 23 comparisons. All trials were at a high risk of bias. We were unable to perform a meta-analysis because there were no two trials involving the same comparison. Primary outcomes included perioperative mortality, serious morbidity and proportion of patients who were discharged on the same day. There were no perioperative deaths or serious adverse events in either group in the only trial that reported this information (0/60). There was no clear evidence of a difference in the proportion of patients who were discharged on the same day between any of the comparisons. Overall, 472/554 patients (85%) included in this review were discharged as day-procedure laparoscopic cholecystectomy patients. Secondary outcomes included hospital readmissions, health-related quality of life, pain, return to activity and return to work. There was no clear evidence of a difference in hospital readmissions within 30 days in the only comparison in which this outcome was reported. One readmission was reported in the 60 patients (2%) in whom this outcome was assessed. Quality of life was not reported in any of the trials. There was no clear evidence of a difference in the pain intensity, measured by a visual analogue scale, between comparators in the only trial which reported the pain intensity at between four and eight hours after surgery. Times to return to activity and return to work were not reported in any of the trials.
AUTHORS' CONCLUSIONS: There is currently insufficient evidence to conclude that one anaesthetic regimen for day-procedure laparoscopic cholecystectomy is to be preferred over another. However, the data are sparse (that is, there were few trials under each comparison and the trials had few participants) and further well designed randomized trials at low risk of bias and which are powered to measure differences in clinically important outcomes are necessary to determine the optimal anaesthetic regimen for day-procedure laparoscopic cholecystectomy, one of the commonest procedures performed in the western world.
日间手术是指挑选合适的患者入院接受预定的外科手术,术后当日即可回家。麻醉方案通常包括镇静剂、诱导剂、维持剂、气道维持方法(喉罩通气与气管插管)和肌肉松弛剂的联合使用。麻醉效果可能在手术结束后仍会持续,从而延迟出院时间。针对日间腹腔镜胆囊切除术,人们提出了各种麻醉方案。
比较不同麻醉方案(死亡率和发病率风险、术后恢复指标)对接受日间腹腔镜胆囊切除术患者的利弊。
我们检索了《 Cochr ane 图书馆》(2013 年第 10 期)中的 Cochr ane 对照试验中心注册库(CENTRAL)、MEDLINE(PubMed)(1987 年至 2013 年 11 月)、EMBASE(OvidSP)(1987 年至 2013 年 11 月)、科学引文索引扩展版(ISI 科学网)(1987 年至 2013 年 11 月)、拉丁美洲及加勒比地区卫生科学数据库(虚拟健康图书馆)(1987 年至 2013 年 11 月)、对照试验元注册库(http://www.controlled-trials.com/mrct/)(2013 年 11 月)、世界卫生组织(WHO)国际临床试验注册平台(ICTRP)门户(2013 年 11 月)以及 ClinicalTrials.gov(2013 年 11 月)。
我们纳入了比较择期日间腹腔镜胆囊切除术期间不同麻醉方案的随机临床试验(不考虑语言或发表状态)。
两位作者独立评估试验是否纳入,并独立提取数据。我们根据意向性分析或现有数据分析计算风险比、率比或均值差及 95%置信区间。
我们纳入了 11 项试验,涉及 1069 名低麻醉风险参与者。样本量从 40 至 300 名参与者不等。我们纳入了 23 组比较。所有试验均存在高度偏倚风险。由于没有两项试验涉及相同的比较,我们无法进行荟萃分析。主要结局包括围手术期死亡率、严重发病率以及当日出院患者比例。在唯一报告此信息的试验中,两组均未出现围手术期死亡或严重不良事件(0/60)。在任何比较中,均无明确证据表明当日出院患者比例存在差异。总体而言,本综述纳入的 554 名患者中有 472 名(85%)作为日间腹腔镜胆囊切除术患者出院。次要结局包括再次入院、健康相关生活质量、疼痛、恢复活动和恢复工作情况。在唯一报告此结局的比较中,无明确证据表明 30 天内再次入院情况存在差异。在评估此结局的 60 名患者中,有 1 例再次入院(2%)。所有试验均未报告生活质量情况。在唯一报告术后 4 至 8 小时疼痛强度的试验中,无明确证据表明比较组之间在视觉模拟量表测量的疼痛强度方面存在差异。所有试验均未报告恢复活动和恢复工作的时间。
目前尚无足够证据得出日间腹腔镜胆囊切除术的一种麻醉方案优于另一种的结论。然而,数据稀少(即每组比较下试验较少且试验参与者较少),需要进一步开展设计良好、偏倚风险低且有足够能力测量临床重要结局差异的随机试验,以确定日间腹腔镜胆囊切除术的最佳麻醉方案,这是西方世界最常见的手术之一。