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临床试验/NCT05827705
NCT05827705已完成不适用

The Effects of Position and Predictive Factors on Hypotension in Patients Undergoing Prone Percutaneous Nephrolithotomy

Bursa Yüksek İhtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
153
试验地点
1
主要终点
Prone position effects on hypotension

研究概览

简要总结

This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged >18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position.

详细描述

This study was designed to investigate the effect of position and predictive factors on hypotension in patients performing percutaneous nephrolithotomy. Patients aged >18 years and ASA I-III who underwent general or regional anaesthesia were included in the study. Percutaneous access was performed in all patients with fluoroscopy in the prone position. Age, gender, body mass index(BMI), smoking, type of anaesthesia, duration of anaesthesia and surgery were recorded.

The ECG, SpO2, and non-invasive blood pressure values were recorded intraoperatively. Preoperative and postoperative 12th hour Hb,BUN, Cr,Na,K and Cl were measured in a blood sample. Isotonic was used as an intravenous fluid in all participants. In treatment of hypotension routine ephedrine treatments were recorded.

In the literature, studies in PCNL surgery have focused on data such as method, duration of bleeding and fluoroscopy, electrolyte-metabolic changes, and complications such as fever, hypothermia, pleural damage, and hospital stay. A limited number of studies have focused on bleeding and hemodynamics in comparing surgical methods in the prone and supine positions. the investigators could not find any study comparing systemic disease effects on intraoperative hypotension (hemodynamic parameters) in Prone PCNL surgery.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged >18 years and ASA I -III who underwent general or regional anaesthesia were included in the study.

排除标准

  • Patients who received preoperative vasopressor, inotropic infusion, erythrocyte and fresh frozen plasma (FFP), anaemia, uncontrolled coagulopathies, pregnancy, immunodeficiency, ASA class IV and emergency surgeries.

结局指标

主要结局

Prone position effects on hypotension

时间窗: Perioperative period

Systolic blood pressure (SBP) \<90 mmHg, mean arterial pressure (MAP) \<65 mmHg, or a decrease of more than 20% of baseline

1.Perioperatif hypotension and presence of systemic diseases

时间窗: Perioperative period

Systolic blood pressure (SBP) \<90 mmHg, mean arterial pressure (MAP) \<65 mmHg, or a decrease of more than 20% of baseline

次要结局

  • mortality(30 days after the surgery)

研究者

发起方
Bursa Yüksek İhtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Seyda Efsun Ozgunay

Asocc Prof

Bursa Yüksek İhtisas Education and Research Hospital

研究点 (1)

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