深度神经肌肉阻滞降低腹腔镜供体肾切除术术中并发症的发生率：随机对照试验的汇总分析
Deep neuromuscular block reduces the incidence of intra-operative complications during laparoscopic donor nephrectomy: a pooled analysis of randomized controlled trials.
作者信息
Reijnders-Boerboom Gabby T J A, van Helden Esmee V, Minnee Robert C, Albers Kim I, Bruintjes Moira H D, Dahan Albert, Martini Chris H, d'Ancona Frank C H, Scheffer Gert-Jan, Keijzer Christiaan, Warlé Michiel C
机构信息
Department of Surgery, Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.
Department of Anaesthesiology, Radboud University Medical Centre, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands.
出版信息
Perioper Med (Lond). 2021 Dec 9;10(1):56. doi: 10.1186/s13741-021-00224-1.
STUDY OBJECTIVE
To assess whether different intensities of intra-abdominal pressure and deep neuromuscular blockade influence the risk of intra-operative surgical complications during laparoscopic donor nephrectomy.
DESIGN
A pooled analysis of ten previously performed prospective randomized controlled trials.
SETTING
Laparoscopic donor nephrectomy performed in four academic hospitals in the Netherlands: Radboudumc, Leiden UMC, Erasmus MC Rotterdam, and Amsterdam UMC.
PATIENTS
Five hundred fifty-six patients undergoing a transperitoneal, fully laparoscopic donor nephrectomy enrolled in ten prospective, randomized controlled trials conducted in the Netherlands from 2001 to 2017.
INTERVENTIONS
Moderate (tetanic count of four > 1) versus deep (post-tetanic count 1-5) neuromuscular blockade and standard (≥10 mmHg) versus low (<10 mmHg) intra-abdominal pressure.
MEASUREMENTS
The primary endpoint is the number of intra-operative surgical complications defined as any deviation from the ideal intra-operative course occurring between skin incision and closure with five severity grades, according to ClassIntra. Multiple logistic regression analyses were used to identify predictors of intra- and postoperative complications.
MAIN RESULTS
In 53/556 (9.5%) patients, an intra-operative complication with ClassIntra grade ≥ 2 occurred. Multiple logistic regression analyses showed standard intra-abdominal pressure (OR 0.318, 95% CI 0.118-0.862; p = 0.024) as a predictor of less intra-operative complications and moderate neuromuscular blockade (OR 3.518, 95% CI 1.244-9.948; p = 0.018) as a predictor of more intra-operative complications. Postoperative complications occurred in 31/556 (6.8%), without significant predictors in multiple logistic regression analyses.
CONCLUSIONS
Our data indicate that the use of deep neuromuscular blockade could increase safety during laparoscopic donor nephrectomy. Future randomized clinical trials should be performed to confirm this and to pursue whether it also applies to other types of laparoscopic surgery.
TRIAL REGISTRATION
Clinicaltrials.gov LEOPARD-2 (NCT02146417), LEOPARD-3 trial (NCT02602964), and RELAX-1 study (NCT02838134), Klop et al. ( NTR 3096 ), Dols et al. 2014 ( NTR1433 ).
研究目的
评估不同强度的腹内压和深度神经肌肉阻滞是否会影响腹腔镜供肾切除术期间术中手术并发症的风险。
设计
对十项先前进行的前瞻性随机对照试验进行汇总分析。
地点
在荷兰的四家学术医院进行腹腔镜供肾切除术：拉德堡德大学医学中心、莱顿大学医学中心、鹿特丹伊拉斯姆斯医学中心和阿姆斯特丹大学医学中心。
患者
556例接受经腹全腹腔镜供肾切除术的患者，纳入了2001年至2017年在荷兰进行的十项前瞻性随机对照试验。
干预措施
中度（强直刺激计数>4）与深度（强直刺激后计数1-5）神经肌肉阻滞，以及标准（≥10 mmHg）与低（<10 mmHg）腹内压。
测量指标
主要终点是术中手术并发症的数量，根据ClassIntra定义为从皮肤切开至缝合期间发生的任何偏离理想术中过程的情况，并分为五个严重程度等级。采用多元逻辑回归分析来确定术中和术后并发症的预测因素。
主要结果
53/556（9.5%）例患者发生了ClassIntra等级≥2的术中并发症。多元逻辑回归分析显示，标准腹内压（比值比0.318，95%可信区间0.118-0.862；p = 0.024）是术中并发症较少的预测因素，中度神经肌肉阻滞（比值比3.518，95%可信区间1.244-9.948；p = 0.018）是术中并发症较多的预测因素。31/556（6.8%）例患者发生了术后并发症，在多元逻辑回归分析中无显著预测因素。
结论
我们的数据表明，深度神经肌肉阻滞的使用可能会提高腹腔镜供肾切除术期间的安全性。未来应进行随机临床试验以证实这一点，并探讨其是否也适用于其他类型的腹腔镜手术。
试验注册
Clinicaltrials.gov上的LEOPARD-2（NCT02146417）、LEOPARD-3试验（NCT02602964）和RELAX-1研究（NCT02838134），克洛普等人（NTR 3096），多尔斯等人2014年（NTR1433）。
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