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Open Access 01-12-2020 | Acute Kidney Injury | Study protocol

Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 × 2 factorial randomized controlled trial

Authors: Xiaohan Xu, Yahong Gong, Yuelun Zhang, Jiaxin Lang, Yuguang Huang

Published in: Trials | Issue 1/2020

Abstract

Background

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.

Methods

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.

Discussion

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.

Trial registration

ClinicalTrials.gov: NCT04259112. Prospectively registered on 5 February 2020.

Available only for authorised users

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Title: Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 × 2 factorial randomized controlled trial
Authors: Xiaohan Xu
Yahong Gong
Yuelun Zhang
Jiaxin Lang
Yuguang Huang
Publication date: 01-12-2020
Publisher: BioMed Central
Keywords: Acute Kidney Injury
Acute Kidney Injury
Published in: Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-020-04477-x

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 × 2 factorial randomized controlled trial

Abstract

Background

Methods

Discussion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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