An Ideal End-tidal Carbon Dioxide Level to Control Intraoperative Bleeding and Improve the Quality of Surgical Field Vision in Septorhinoplasty Operations Under General Anesthesia: a Prospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Quality of the intraoperative surgical field
研究概览
简要总结
It is unknown whether different end-tidal carbon dioxide pressure levels have a clinically significant effect on bleeding and surgical field quality in septorhinoplasty, especially during controlled hypotension. Therefore, it was aimed to investigate the effect of ventilation strategy with controlled hypocapnia on intraoperative bleeding and surgical field quality for commonly practiced in septorhinoplasty.
详细描述
Septorhinoplasty is one of the most common esthetic surgeries in the world. The septorhinoplasty is accompanied by insignificant bleeding on the surgical field. Excessive bleeding compromises the surgical field quality and makes more difficult the septorhinoplasty. It is very important to control and minimize excessive bleeding in surgical field by different approaches of anesthesia management. Successful approaches to reduce the excessive bleeding are; controlled hypotension by keeping the mean arterial pressure in the range of 60-70 mmHg, the reverse Trendelenburg position of the patient, administration of adrenaline (injection prior to surgery or packing soaked during surgery), and administration of tranexamic acid, which are applicable methods in many clinical centers.
Cardiac output may vary depending on the autonomic nervous system. The dominance of parasympathetic system effect may cause vasodilation, decrease in blood pressure and cardiac output. This vasodilation may increase bleeding during septorhinoplasty and worsen the surgical field quality. Anesthesia management may provide a clear view for the surgeon and an improved surgical field quality. The effect of carbon dioxide on vascular reactivity deserves an extra attention in septorhinoplasty required bleeding control. The intensity of bleeding in septorhinoplasty is mainly affected by mean arterial pressure and heart rate. At the same time, blood flow can be affected directly by carbon dioxide on the smooth muscular tonus of the arterioles.
After all, it is unknown whether different carbon dioxide pressure levels have a clinically significant effect on bleeding and surgical field quality in septorhinoplasty, especially during controlled hypotension. Therefore, it was aimed to investigate the effect of ventilation strategy with controlled hypocapnia on intraoperative bleeding and surgical field quality for commonly practiced in septorhinoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists scores 1-3
- •18-65 years
排除标准
- •American Society of Anesthesiologists scores IV,
- •Under the age of 18,
- •Over the age of 65,
- •Using anticoagulant and antiplatelet drugs,
- •Previous underwent septorhinoplasty operation,
- •Obstetric conditions,
- •Cardiovascular and pulmonary disease,
- •Uncontrolled cerebrovascular disease,
- •Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and tramadol,
- •Refused written informed consent
结局指标
主要结局
Quality of the intraoperative surgical field
时间窗: Quality of the intraoperative surgical field will be performed to surgeon 30 minutes after the procedure
Quality of the intraoperative surgical field will be measured on a grade of 0-10 (0-1. no bleeding, 2-3. mild bleeding, 4-5. Mild to moderate bleeding, 6-7. moderate bleeding, 8-9. moderate to severe bleeding, 10. Severe bleeding)
Total amount of intraoperative bleeding
时间窗: From beginning of surgery to end of surgery
Total amount of intraoperative bleeding will be calculated in milliliters after the end of surgery.
Surgeon Satisfaction
时间窗: Surgeon Satisfaction will be performed to surgeon 30 minutes after the procedure
Surgeon Satisfaction will be measured on a grade of 0-5 (1= very bad, 2= bad, 3= moderate, 4= good, 5= very good).
次要结局
- Heart rate(From beginning of Anesthesia induction to the end of anesthesia (during perioperative period))
- Mean arterial pressure(From beginning of Anesthesia induction to the end of anesthesia (during perioperative period))
- Peripheral oxygen saturation(From beginning of Anesthesia induction to the end of anesthesia (during perioperative period))
研究者
Muhittin Calim
Principal Investigator
Bezmialem Vakif University