The Influence of Blood Pressure Upon the Clarity of Surgical Field in Endonasal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Surgical field clarity in relation to the value of arterial pressure
研究概览
简要总结
The work compares the effect of different various values of arterial blood pressure on the clarity of the surgical field in pansinusoperation in patients with chronic rhinosinusitis.
详细描述
The work compares the effect of different values of arterial pressure on the clarity of the surgical field in pansinus operation in patients with chronic rhinosinusitis. A secondary goal of the study is to compare circulatory parameters, depth of anaesthesia, near-infrared spectroscopy (NIRS) and consumption of hypotensives.
Null hypothesis: There is no difference in the clarity of the surgical field at various levels of the mean arterial pressure.
This study is being realized in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee of the University Hospital Ostrava (849/2018). According to the statement of the State Institute for Drug Control of 26th April 2019 (reference number Sukl96964/2019), the trial is not considered a clinical trial of medicinal products.
Study type: Single-blind study (the surgeon does not know the value of the patient's blood pressure) prospective study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The physician performing the surgery and assessing the surgical field clarity will be masked as to the value of the blood pressure in the individual patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic rhinosinusitis undergoing pansinusoperation
- •Age over 18 years
- •Concrete surgeon (Petr Matoušek, MD, Ph.D., MBA)
- •Concrete anaesthetist (Michal Parma, MD)
排除标准
- •Coagulopathy
- •Thrombocytopathies
- •Vascular wall disorders
- •Thrombophlebitis
- •Anticoagulation or anti-aggregation therapy
- •History of malignancy
- •Pregnancy
结局指标
主要结局
Surgical field clarity in relation to the value of arterial pressure
时间窗: 13 months
Clarity of the surgical field will be assessed on a scale of 0-5, according to the Boezaart's system (1995)
次要结局
- Blood loss(13 months)
- Postoperative pain(13 months)
- Near infrared spectroscopy (NIRS)(13 months)
- Recovery from anaesthesia duration(13 months)
- Cognitive function(13 months)
- Complications of controlled hypotension(13 months)
- Use of tamponade(13 months)
- Surgical revision(13 months)
- Heart rate(13 months)
- Blood pressure(13 months)
- Depth of anaesthesia(13 months)
- Consumption of hypotensives(13 months)
- Postoperative vomiting(13 months)
- Postoperative nausea(13 months)