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临床试验/NCT02315482
NCT02315482已完成不适用

Effect of Pneumoperitoneum and Steep Trendelenburg on Autonomic Nervous System

ASST Fatebenefratelli Sacco4 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
52
试验地点
4
主要终点
changes of High Frequency and Low Frequency spectral heart rate power induced by pneumoperitoneum and steep trendelenburg

研究概览

简要总结

The purpose of this study is to assess the different effects of pneumoperitoneum and steep trendelenburg position on autonomic nervous system modulation during laparoscopic prostatectomy

详细描述

Laparoscopic radical prostatectomy is becoming a widely used surgical procedure because it carries some important advantages over open prostatectomy. This surgical technique requires positioning the patient at 25-40 degree head-down position (steep trendelenburg) for a prolonged time in association with pneumoperitoneum at 12-15 mmHg. The postural change from supine to head down position causes a hydrostatic fluid shift towards the head and the thorax, thus increasing venous return and stimulating the cardiopulmonary baroreceptors. Moreover, there are reports of severe bradycardia and cardiac arrest following pneumoperitoneum in association with steep trendelenburg. A vagal hypertone induced by the combination of these two factors, or sympathetic hyperactivity elicited by pneumoperitoneum insufflation have been alternatively advocated as a cause of such hemodynamic changes. However these speculations are little more than a narrative role because any evidence based demonstration is never been provided.

The aim of this study is to measure the variations of autonomic nervous system modulation induced by steep trendelenburg position at 25 degrees and pneumoperitoneum during laparoscopic radical prostatectomy.

Methods Patients are randomized into two groups. Group A: after induction of general anesthesia, in supine position a pneumoperitoneum is induced with carbon dioxide insufflation through a surgical inserted trocar into the abdominal cavity, then patients are positioned in steep trendelenburg at 25 degrees head down. Group B: after induction of general anesthesia, patients are positioned in steep trendelenburg position at 25 degrees head down, then a pneumoperitoneum is induced with carbon dioxide insufflation through a surgical inserted trocar into the abdominal cavity.

Autonomic nervous system modulation is assessed at four main time: (i) T1 baseline (before the induction of general anesthesia); (ii) T2, 5 min after the induction of general anesthesia, (iii) T3, pneumoperitoneum insufflation (Group A) or steep trendelenburg (Group B); (iv) T4, steep trendelenburg (Group A) or pneumoperitoneum insufflation (Group B).

Autonomic nervous system modulation is studied non invasively by means of heart rate variability (HRV) analysis through both linear and non linear methods. Beat-to-beat intervals are computed detecting the QRS complex on the electrocardiogram and locating the R-apex using parabolic interpolation. The maximum arterial pressure within each R-to-R interval is taken as systolic arterial pressure (SAP). Sequences of 300 values are randomly selected inside each experimental condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • males scheduled for elective laparoscopic prostatectomy
  • sinus rhythm at electrocardiogram
  • ectopic heart beats <5% of all heart beats
  • american society of anesthesiologists status 1-3

排除标准

  • autonomic dysfunction (documented or suspected)
  • adrenal or thyroid dysfunction
  • organ dysfunction secondary to diabetes (i.e. nephropathy, retinopathy, neuropathy)
  • history of stroke, traumatic spinal injury, heart surgery or major vascular surgery
  • intracranial hypertension (documented or suspected)
  • hydrocephalus
  • New York Heart Association cardiac functional status ≥ IIb
  • non sinusal heart rhythm
  • ectopic heart beats ≥5% of normal heart beats
  • therapy with beta-blockers or beta2-agonists

结局指标

主要结局

changes of High Frequency and Low Frequency spectral heart rate power induced by pneumoperitoneum and steep trendelenburg

时间窗: 60 min

changes of autonomic nervous system activity independently elicited by (i) pneumoperitoneum and (ii) steep trendelenburg position. The High Frequency and Low Frequency spectral power of beat-to-beat heart intervals will be assessed with autoregressive analysis and expressed in msec\^2

次要结局

  • changes of symbolic patterns induced by pneumoperitoneum and steep trendelenburg(60 min)

研究者

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

Riccardo Colombo

Autonomic activity during laparoscopic prostatectomy

ASST Fatebenefratelli Sacco

研究点 (4)

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