跳至主要内容
临床试验/NCT02129959
NCT02129959Unknown不适用

Cardiovascular Effects of the Degree of Head-down and Pneumoperitoneum During Laparoscopy

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
180
试验地点
1
主要终点
cardiovascular effects

研究概览

简要总结

The aim of this study is to observe the cardiovascular effects of the degree of head-down angle and pneumoperitoneum during laparoscopic procedure using by the fourth version Vigileo-Flotrac system.

详细描述

Laparoscopy for general surgery followed and proved to be advantageous in reduction of postoperative pain, better cosmetic results, quicker return to normal activities, reduction in hospital stay resulting in overall reduction in medical cost, less intraoperative bleeding, less postoperative pulmonary complications, less postoperative wound infection, reduced metabolic derangement, and better postoperative respiratory function. In recent years, advanced laparoscopic surgery has targeted older and sicker patients, rendering anesthesia during laparoscopy more technically demanding. Robotic-assisted laparoscopic radical prostatectomy is rapidly becoming a part of the standard surgical repertoire for the treatment of prostate cancer. Robotic-assisted laparoscopic radical prostatectomy are primarily related to the use of pneumoperitoneum in the steep Trendelenburg position. This combination will affect cerebrovascular, respiratory and hemodynamic homeostasis. The golden standard method for measuring cardiac output in the clinical setting is thermodilution using a pulmonary artery catheter, but the risk of pulmonary artery catheter insertion can not be justified in routine cases. The Vigileo-FloTrac system (Edwards Lifesciences, Irvine, CA, USA), is a less invasive method to obtain continuous CO using pulse contour analysis. The aim of this study is to observe the cardiovascular effects of the degree of head-down angle and pneumoperitoneum during laparoscopic procedure using by the fourth version Vigileo-Flotrac system.

We choose 180 ASA physical status I to III patients undergoing laparoscopic surgery are enrolled in this study. These surgical procedures include laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic colectomy, laparoscopic appendectomy, laparoscopic assisted vaginal hysterectomy, robot-assisted laparoscopic radical prostatectomy. These surgical procedures provide the information about the different degree of head-down angle and different intra-abdominal pressure of pneumoperitoneum. Hemodynamic data are recorded immediately after induction of anesthesia; 5 min after induction of pneumoperitoneum; 5, 15, 30, 60 min, and every 30 min if duration more than 60 min after placement in the Trendelenburg position with pneumoperitoneum; and the end.

After observing the cardiovascular effects of degree of head-down, insufflation pressure, duration of surgery, we can prevent the possible complications in advance during laparoscopic surgery. After completing the study, we will be familiar with the use of Vigileo-FloTrac system. We will have more experiences to deal with high-risk patients undergoing simple surgical procedure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ASA physical status I to III patients undergoing laparoscopic surgery are enrolled in this study.

排除标准

  • •preoperative ECG reports and severe obesity (body mass index ≥35 kg/m2)

结局指标

主要结局

cardiovascular effects

时间窗: one year

Hemodynamic data are recorded immediately after induction of anesthesia; 5 min after induction of pneumoperitoneum; 5, 15, 30, 60 min, and every 30 min if duration more than 60 min after placement in the Trendelenburg position with pneumoperitoneum; and the end.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

National Taiwan University Hospital

VS

National Taiwan University Hospital

研究点 (1)

Loading locations...

相似试验