Laparoscopic Surgery: Comparison of Intraoperative Hemodynamic Parameters and Arterial-blood Gas Changes at Two Different Pneumoperitoneal Pressure Values
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- arterial blood pressure
研究概览
简要总结
Clinic and metabolic consequences of pneumoperitoneum, achieved by insufflation of gas carbon dioxide, are still debated. Cardiovascular system suffering due to the compression of intra-abdominal venous structures can cause life-threatening complications. Increased partial pressure of carbon dioxide induces metabolic acidosis with further vascular suffering. Pneumoperitoneum reduces the pulmonary exchange volumes and bring renal suffering.
Methods. The aim of this study is to evaluate the alterations in hemodynamic and hemogasanalysis parameters during the laparoscopic surgery at different pressure settings of pneumoperitoneum in order to assess the best pressure value.
We evaluated and compared intraoperative hemodynamic and hemogasanalytic alterations in two groups of patients respectively subdue to laparoscopic cholecystectomy at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B).
详细描述
We evaluated intraoperative hemodynamic and hemogasanalytic alterations in two groups of randomized patients respectively operated at a pneumoperitoneum pressure of 12 mmHg (group A) and at a pressure of 8 mmHg (group B) to highlight any significant alterations.
The clinical sample used in the study is composed by patients aged between 15 and 85 years affected by cholelithiasis and treated with laparoscopic cholecystectomy in the period between July 2019 and February 2020.
20 patients, 9 men and 11 women, were enrolled. Group A included 10 patients, 5 men and 5 women, with an average age of 47.9 years. Group B included 10 patients, 4 men and 6 women, with an average age of 50.7 years.
The parameters evaluated were: heart rate (HR), average arterial blood pressure (BP), respiratory frequency (RF), oxygen saturation (SaO2), hemogasanalysis (PaO2, PaCO2, pH and HCO3-).
The measurements were made at four stages: before the induction of anesthesia, after the anesthesia induction but before incision, 30 minutes after the pneumoperitoneum induction, 5 minutes after the pneumoperitoneum releasing.
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
- 15 Years 至 85 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •cholelithiasis -
排除标准
- •immunodeficiency disorders, chronic use of corticosteroids, non-compensated diabetes mellitus, major morbidity with a life expectancy of less than 30 days, significant anemia (hemoglobin < 7 gr/Dl or hematocrit < 21%), coagulopathies, ascites, chronic pain treatment, severe comorbidities
结局指标
主要结局
arterial blood pressure
时间窗: 5 minutes after the pneumoperitoneum releasing
average arterial blood pressure variations
respiratory frequency
时间窗: 5 minutes after the pneumoperitoneum releasing
respiratory frequency variations
hearth rate
时间窗: 5 minutes after the pneumoperitoneum releasing
hearth rate variations
oxygen saturation
时间窗: 5 minutes after the pneumoperitoneum releasing
oxygen saturation variations
blood gas analysis
时间窗: 5 minutes after the pneumoperitoneum releasing
blood gas analysis variations
次要结局
未报告次要终点
研究者
Eva Intagliata
researcher
University of Catania
