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临床试验/NCT03931759
NCT03931759Unknown不适用

The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed With Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics

Erzincan University0 个研究点目标入组 130 人开始时间: 2019年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
130
主要终点
The measurement of heart rate variability in laparoscopic surgeries

研究概览

简要总结

The Effect of Intra-abdominal Pressure

详细描述

The Effect of Intra-abdominal Pressure, Applied to the Patients Diagnosed with Diabetes Mellitus, Who Undergo Laparoscopic Surgery, on Hemodynamics

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Screening
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diabetes mellitus
  • laparoscopic surgery

排除标准

  • hypertension
  • hearth failure
  • renal failure
  • hepatic failure
  • difficult intubation

研究组 & 干预措施

Diabetes mellitus

Active Comparator

patients with diabetes mellitus

干预措施: laparoscopic surgery (Diagnostic Test)

non-Diabetes mellitus

No Intervention

patients without diabetes mellitus

结局指标

主要结局

The measurement of heart rate variability in laparoscopic surgeries

时间窗: 1 year

The measurement of heart rate variability is used as a method to assess the autonomic nerve system. As the autonomic nerve system dysfunction may complicate the possible peroperative problems in the patients to be operated, the pre-assessment of the autonomic nerve system function should be considered as an acquisition required to be obtained in the daily anesthesia practice. When we increase the intraabdominal pressure during the laparoscopic surgery, we think that the hemodynamic responses of the diabetic patient group, especially the patients with autonomic neuropathy, to this increasing intraabdominal pressure will be different. The aim of the present study is to investigate the effect of the intraabdominal pressure, applied to the patients diagnosed with diabetes mellitus who will have laparoscopic surgery, on hemodynamics.

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

Nurhan EREN

research assistant

Erzincan University

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