title: Comparison of the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery in the Trendelenburg position: study protocol for a randomized controlled trial.
abstract: Robot-assisted laparoscopic radical prostatectomy and robot-assisted radical cystectomy have gradually become the preferred choices for urologists as they allow surgeons to perform complex procedures more precisely and effectively. The pneumoperitoneum, which is normally applied in these surgeries to provide visual clarity and space to perform the procedure, may cause hemodynamic disturbance, potentially myocardial injury. Thus surgeons have recently considered opting for the low-pressure pneumoperitoneum to lower this negative impact. Herein we describe a protocol for a clinical trial to compare the impact of prolonged low-pressure and standard-pressure pneumoperitoneum on myocardial injury after robot-assisted surgery.
  
  
  
  This study is designed to be a bicenter clinical trial. In total 280 patients scheduled to undergo robot-assisted laparoscopic radical prostatectomy or robot-assisted radical cystectomy will be enrolled and randomized into two groups, with standard- (12-16 mmHg) and low-pressure (7-10 mmHg) pneumoperitoneum, respectively. Troponin T will be measured as the primary endpoint to assess the extent of myocardial injury. Nt-proBNP and hemodynamic indexes will also be recorded for further analysis.
  
  
  
  The significance of this study is emphasized by the fact that there are few studies that have focused on the impact of prolonged pneumoperitoneum on myocardial injury, which is relevant to postoperative mortality. We hope that the conclusions drawn from this study could provide reference and basis to the future of the pneumoperitoneum in clinical practice.
  
  
  
  Registered at https://www.clinicaltrials.gov with the Identifier NCT02600481 on November 5, 2015.
authors.affiliation: Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Xixue
authors.initials: X
authors.lastname: Zhang
authors.affiliation: Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Jionglin
authors.initials: J
authors.lastname: Wei
authors.affiliation: Department of Anesthesiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Xiaoxing
authors.initials: X
authors.lastname: Song
authors.affiliation: Department of Anesthesiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Yuhao
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Urology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Weiqing
authors.initials: W
authors.lastname: Qian
authors.affiliation: Department of Urology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Lu
authors.initials: L
authors.lastname: Sheng
authors.affiliation: Department of Urology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Zhoujun
authors.initials: Z
authors.lastname: Shen
authors.affiliation: Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, China.
authors.forename: Lvjun
authors.initials: L
authors.lastname: Yang
authors.affiliation: Department of Anesthesiology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. sally9132@163.com.
authors.forename: Rong
authors.initials: R
authors.lastname: Dong
authors.affiliation: Department of Anesthesiology, Huadong Hospital Affiliated to Fudan University, Shanghai, China. wdgu_hdh@163.com.
authors.forename: Weidong
authors.initials: W
authors.lastname: Gu
mesh_terms: D002985:Clinical Protocols; D015653:Cystectomy; D018475:Head-Down Tilt; D006331:Heart Diseases / Q000209:etiology*; D006801:Humans; D011028:Pneumoperitoneum, Artificial / Q000379:methods*; D011183:Postoperative Complications / Q000209:etiology*; D011312:Pressure; D011446:Prospective Studies; D011468:Prostatectomy; D065287:Robotic Surgical Procedures / Q000009:adverse effects*; D016037:Single-Blind Method; D020107:Troponin T / Q000097:blood
chemical_list: D020107:Troponin T
keywords: Low-pressure pneumoperitoneum; Myocardial injury; Robot-assisted urological surgery; Standard-pressure pneumoperitoneum; Trendelenburg position; Troponin T