Department of Anesthesiology, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.
Department of Medical Research Center, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.
Trials. 2020 Jun 29;21(1):585. doi: 10.1186/s13063-020-04477-x.
Patients with diabetes mellitus are at a high risk of developing postoperative acute kidney injury. For patients receiving laparoscopic surgery, standard-pressure pneumoperitoneum (SPP) currently applied in clinical practice also undermines renal perfusion. Several studies have shown that low-pressure pneumoperitoneum (LPP) might reduce pressure-related ischemic renal injury. However, LPP may compromise the view of the surgical field. Previous studies have indicated that deep neuromuscular blockade (NMB) can ameliorate this issue. However, the conclusion is still uncertain. The hypothesis of this study is that the joint use of LPP and deep NMB can reduce perioperative renal injury in diabetic patients undergoing laparoscopic pelvic surgery without impeding the view of the surgical field.
This is a double-blinded, randomized controlled trial using a 2 × 2 factorial trial design. A total of 648 diabetes patients scheduled for major laparoscopic pelvic surgeries at Peking Union Medical College Hospital will be randomized into the following four groups: SPP (12-15 mmHg) + deep-NMB (post-tetanic count of 1-2) group, LPP (7-10 mmHg) + deep-NMB group, SPP + moderate-NMB (train-of-four of 1-2) group, and LPP + moderate-NMB group. The primary outcome is serum cystatin C level measured before insufflation, after deflation, 24 h postoperatively, and 72 h postoperatively. The secondary outcomes are serum creatinine level, intraoperative urine output, erythrocytes in urinary sediment, renal tissue oxygen saturation, Leiden's surgical condition rating scale, surgery duration, and occurrence of bucking or body movement.
This study will provide evidence for the effect of LPP on renal function protection in patients with diabetes undergoing laparoscopic pelvic surgery. The trial can also help us to understand whether deep NMB can improve surgical conditions.
ClinicalTrials.gov : NCT04259112 . Prospectively registered on 5 February 2020.
糖尿病患者发生术后急性肾损伤的风险较高。对于接受腹腔镜手术的患者，目前临床实践中应用的标准压力气腹（SPP）也会破坏肾脏灌注。多项研究表明，低压气腹（LPP）可能会减轻与压力相关的缺血性肾损伤。然而，LPP 可能会影响手术视野。先前的研究表明，深度神经肌肉阻滞（NMB）可以改善这一问题。但是，结论仍不确定。本研究的假设是，联合使用 LPP 和深度 NMB 可以减少行腹腔镜盆腔手术的糖尿病患者围手术期的肾损伤，而不会影响手术视野。
这是一项采用 2×2 析因试验设计的双盲、随机对照试验。共有 648 名计划在我院行大型腹腔镜盆腔手术的糖尿病患者将被随机分为以下四组：SPP（12-15mmHg）+深度-NMB（强直后计数 1-2）组、LPP（7-10mmHg）+深度-NMB 组、SPP+中度-NMB（四成比 1-2）组和 LPP+中度-NMB 组。主要结局是测量充气前、放气后、术后 24 小时和术后 72 小时的血清胱抑素 C 水平。次要结局是血清肌酐水平、术中尿量、尿沉渣中红细胞、肾组织氧饱和度、莱顿手术条件评分、手术时间和出现颠簸或身体运动的情况。
本研究将为糖尿病患者行腹腔镜盆腔手术时 LPP 对肾功能的保护作用提供证据。该试验还可以帮助我们了解深度 NMB 是否可以改善手术条件。
ClinicalTrials.gov：NCT04259112。于 2020 年 2 月 5 日前瞻性注册。
