Abstract
BackgroundPatients 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.MethodsThis 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.DiscussionThis 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.Trial registrationClinicalTrials.gov: NCT04259112. Prospectively registered on 5 February 2020.
Highlights
Patients with diabetes mellitus are at a high risk of developing postoperative acute kidney injury
According to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) criteria, acute kidney injury (AKI) refers to the sudden decrease in renal function, defined by an elevation in serum creatinine (Cr) level or a decrease in urine output [13]
To the best of our knowledge, this is the first trial to date assessing the effects of pneumoperitoneum pressure and neuromuscular blockade (NMB) on postoperative renal function in diabetes patients
Summary
Patients with diabetes mellitus are at a high risk of developing postoperative acute kidney injury. 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. In China, the prevalence of diabetic kidney disease is as high as 24.3% in patients with type 2 diabetes [3], making it the leading cause of end-stage renal disease (ESRD) [4]. Postoperative acute kidney injury (AKI) affects 13– 20% of patients undergoing major surgery [6, 7] and is associated with substantial morbidity and mortality [8, 9]. Pre-existing chronic kidney disease, including diabetic kidney disease, is associated with an increased risk of postoperative AKI [10]. Renal oxygen saturation is a promising predictor for AKI [16, 17]
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