Effects of Steep Trendelenburg and Pneumoperitoneum on Cardiac Performance During Robotic-assisted Surgery in Patients With Normal and Low Ejection Fraction.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change of Stroke Volume during Trendelenburg position and pneumoperitoneum.
研究概览
简要总结
The field of robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients which are not suitable for major open surgery could be scheduled for robotic- assisted surgery. The peroperative anesthesiological challenges and stresses during this type of surgery could anyway be even more prominent.
The extreme positioning of patients during robotic surgery in the pelvis, often 30 degrees head down tilting (Trendelenburg positioning), should increase the work load of the heart significantly. There are no studies concerning fragile patients with heart failure during these conditions.
In this study the circulatory effects in patients with normal heart function and preexisting heart failure will be studied during robotic surgery in extreme Trendelenburg positioning
During surgery the work load and performance of the heart will be monitored using an esophageal doppler and optical spectrophotometry measuring regional saturation of the brain. This study can identify patients at risk of developing critical circulatory failure during this type of surgery.
详细描述
BACKGROUND:
The development of robotic-assisted laparoscopic surgery is rapid. It is at least more gentle than open surgery to the patient. During certain types of robotic-surgery i.e. prostatectomies and hysterectomies deep down in the small pelvis the surgeons need to tilt the patient in a steep Trendelenburg (30 degrees head down) position and insufflate CO2 (carbon dioxide) gas into the stomach to reach and visualize the organs properly.
According to the law of gravity this entails that the blood inside the vessels is pressed backwards against the pumping heart and afterload increases. To be able to withhold the flow of blood to our vital organs the performance of our heart is challenged. Besides carbon dioxide is blown into the stomach, which even more increases the workload of the heart. There is a substantial risk of acute heart failure during these manoeuvres especially in patients with preexisting heart failure.
There are very few studies investigating these problems. Earlier studies have only investigated the effects in healthy ASA (American Society of Anesthesiologists) 1-2 patients.
AIM:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •1. Consecutive Patients Scheduled for Robotic Surgery with Trendelenburg positioning.
排除标准
- •Not able to give written consent -
研究组 & 干预措施
Patients with Preoperative EF: 50% or higher
Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured.
干预措施: Esophageal Doppler (Device)
Patients with Preoperative EF: 45% or lower
Patients included will be examined with Transthoracic Echocardiography preoperatively and Ejection Fraction (EF) measured.
干预措施: Esophageal Doppler (Device)
Patients without intrathecal bupivacain and morphine.
The routine is that all patient receive an intrathecal injection of morphine and bupivacain before start of anesthesia. Patients who have contraindications for spinal anesthesia will be collected in this group.
干预措施: Esophageal Doppler (Device)
结局指标
主要结局
Change of Stroke Volume during Trendelenburg position and pneumoperitoneum.
时间窗: During 15 minutes after reaching position.
Esophageal Doppler Monitoring
次要结局
- % Change of Systemic Vascular Resistance;PulsePressureVariation; Peak Velocity; Stroke Volume Variation and FlowTimeCorrected(During 15 minutes after reaching position)
- % change in regional brain saturation rSO2 during Trendelenburg position and pneumooperitoneum.(During 15 min after reaching position.)
研究者
Ragnar Henningsson
Associate Professor
Karlstad Central Hospital