Comparison of the Perioperative Effects of Intra-abdominal Pressure Created With Standard and Valveless Insufflators in Robotic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of manipulations done by the attending anesthesiologists
研究概览
简要总结
The main aim of this study is to compare the perioperative effects of different intra-abdominal pressures and different insufflators in patients undergoing robotic surgery at a 30-45 degree trendelenburg position.
详细描述
Adult patients scheduled for robotic genitourinary or colorectal surgery are going to be enrolled in this study. Patients will be randomized in three groups. In group I, conventional insufflators will be used with 12 mmHg intra-abdominal pressure; in group II, valveless insufflators will be used with 12 mmHg intra-abdominal pressure and in group III, valveless insufflators will be used with 8 mmHg intra-abdominal pressure. Intraoperative data regarding airway pressures, lung compliance, hemodynamic parameters, arterial blood gas analysis, times of pressure loss and camera cleaning will be gathered. Each patient will receive a standardized anesthesia and analgesia procedure with a intravenous morphine patient controlled analgesia (PCA). Postoperative pain will be monitored at 1st, 3rd, 6th, 12th and 24th postoperative hours and morphine consumption rates will be recorded. Patient length of stay, time to first flatus, urine output, postoperative complications(graded by Clavien Dindo classification), preoperative and postoperative hemoglobin and creatinine levels will be filed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
The patient and the pain nurses will be blind to the intervention due to the study design.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective robotic surgery with intraabdominal insufflation and trendelenburg position (prostatectomy, hemicolectomy etc.)
- •ASA (American Society of Anesthesiologists) Physical Status I-II-III
排除标准
- •Patients without consent
- •Emergency surgery
- •Bleeding diathesis
- •Pregnancy or lactation
- •Prior history of major abdominal/pelvic surgery
- •Chronic kidney disease
- •Chronic opioid consumption for chronic pain
- •Inability to communicate with the patient due to language barriers or mental status
研究组 & 干预措施
Valveless 12
Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 12 mmHg intra-abdominal pressure.
干预措施: Valveless Insufflator with 12 mmHg intra-abdominal pressure (Device)
Valveless 8
Patients scheduled for genitourinary or colorectal robotic surgery, valveless insufflators will be used with 8 mmHg intra-abdominal pressure.
干预措施: Valveless Insufflator with 8 mmHg intra-abdominal pressure (Device)
结局指标
主要结局
Number of manipulations done by the attending anesthesiologists
时间窗: Intraoperative
After the induction of general anesthesia, orotracheal intubation and arterial catheterization; a standard ventilation and anesthesia maintenance strategy will be applied. Every manipulation performed to keep the parameters monitored by the anesthesiologists within physiological limits will be recorded: ventilation frequency setting, remifentail infusion titration, administration of vasoactive agents, etc.
次要结局
- Arterial blood gas lactate levels(Intraoperative)
- Peak airway pressures(Intraoperative)
- Systolic blood pressure(Intraoperative)
- Diastolic blood pressure(Intraoperative)
- Acute Postoperative Pain(Postoperative 24 hours)
- Postoperative morphine consumption(Postoperative 24 hours)
- Anesthesia time and operative time(Intraoperative)
- Urine output(Intraoperative and daily untill discharge)
- Mean airway pressures(Intraoperative)
- Lung compliance(Intraoperative)
- End tidal carbon dioxide levels(Intraoperative)
- Minute ventilation(Intraoperative)
- Heart rate(Intraoperative)
- Mean blood pressure(Intraoperative)
- Intraoperative bleeding(Intraoperative)
- Number of participants with pulmonary complications(Postoperative, up to one month)
- Time to oral intake(Postoperative 3 days)
- Creatinine levels(Preoperative and postoperative (up to one month))
- Need for blood product transfusion(Intraoperative and daily untill discharge)
- Hemoglobin levels(Intraoperative and daily untill discharge)
- Flatus time(Postoperative one week)
- Number of participants with subcutaneous emphysema(Postoperative, up to one month)
- Length of hospital stay(Postoperative, up to one month)
- The Clavien-Dindo classification of surgical complications(Postoperative, up to one month)