Cargando…
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
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 tha...
Autores principales: | , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2020
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322917/ https://www.ncbi.nlm.nih.gov/pubmed/32600358 http://dx.doi.org/10.1186/s13063-020-04477-x |
_version_ | 1783551734992338944 |
---|---|
author | Xu, Xiaohan Gong, Yahong Zhang, Yuelun Lang, Jiaxin Huang, Yuguang |
author_facet | Xu, Xiaohan Gong, Yahong Zhang, Yuelun Lang, Jiaxin Huang, Yuguang |
author_sort | Xu, Xiaohan |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7322917 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-73229172020-06-30 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 Xu, Xiaohan Gong, Yahong Zhang, Yuelun Lang, Jiaxin Huang, Yuguang Trials Study Protocol 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. BioMed Central 2020-06-29 /pmc/articles/PMC7322917/ /pubmed/32600358 http://dx.doi.org/10.1186/s13063-020-04477-x Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Xu, Xiaohan Gong, Yahong Zhang, Yuelun Lang, Jiaxin Huang, Yuguang 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322917/ https://www.ncbi.nlm.nih.gov/pubmed/32600358 http://dx.doi.org/10.1186/s13063-020-04477-x |
work_keys_str_mv | AT xuxiaohan effectofpneumoperitoneumpressureandthedepthofneuromuscularblockonrenalfunctioninpatientswithdiabetesundergoinglaparoscopicpelvicsurgerystudyprotocolforadoubleblinded22factorialrandomizedcontrolledtrial AT gongyahong effectofpneumoperitoneumpressureandthedepthofneuromuscularblockonrenalfunctioninpatientswithdiabetesundergoinglaparoscopicpelvicsurgerystudyprotocolforadoubleblinded22factorialrandomizedcontrolledtrial AT zhangyuelun effectofpneumoperitoneumpressureandthedepthofneuromuscularblockonrenalfunctioninpatientswithdiabetesundergoinglaparoscopicpelvicsurgerystudyprotocolforadoubleblinded22factorialrandomizedcontrolledtrial AT langjiaxin effectofpneumoperitoneumpressureandthedepthofneuromuscularblockonrenalfunctioninpatientswithdiabetesundergoinglaparoscopicpelvicsurgerystudyprotocolforadoubleblinded22factorialrandomizedcontrolledtrial AT huangyuguang effectofpneumoperitoneumpressureandthedepthofneuromuscularblockonrenalfunctioninpatientswithdiabetesundergoinglaparoscopicpelvicsurgerystudyprotocolforadoubleblinded22factorialrandomizedcontrolledtrial |