Opioid Free Anesthesia Versus Conventional Total Intravenous Anesthesia for ENT Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain management
研究概览
简要总结
Opioid Free Anesthesia (OFA) - which has been applied mainly in bariatric surgery - has begun to receive more and more attention and to obtain fanatical supporters versus conventional anesthesia. The advantages of this type of anesthesia are mainly achieved by the action and effect of the various drugs that compose it.
Functional Endoscopic Sinus Surgery is performed in cases where sinusitis or its complications are difficult to treat with medication. With special cameras and endoscopes, the narrow anatomical regions of the sinus can be depicted and precisely surgically approached. Usually surgery is conducted under general anesthesia. According to the literature, total intravenous anesthesia should be used for sinus surgery to achieve blood pressure control as well as controlled hypotension to prevent intraoperative bleeding. Most of the studies agree that the best type of anesthesia for this type of surgery is total intravenous anesthesia. When it comes to Opioid Free Anesthesia in FESS, there are not many studies, except of some studies that don't use solely Opioid Free Anesthesia but some of the drugs that consist it.
Patients scheduled for elective Functional Endoscopic Sinus Surgery will be randomised in two groups. One receiving OFA and one receiving TIVA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 - 75 years old
- •Elective FESS
排除标准
- •Patients < 18 or >75 years of age
- •Patients who can't read of speak the Greek language
- •Patients with psychiatric disorders
- •Patients with atrioventricular block in ECG
- •Patients with musculoskeletal disorders
- •Patients with coronary artery disease
- •Patients uncapable of giving informed consent
研究组 & 干预措施
OFA Group
patients undergoing FESS under opiod free anesthesia
干预措施: Dexmedetomidine (Drug)
TIVA Group
patients undergoing FESS under total intravenous anesthesia
干预措施: Remifentanil (Drug)
结局指标
主要结局
Pain management
时间窗: 48 hours
Visual Analogue Scale score for pain after FESS
Intraoperative bleeding in the surgical field
时间窗: intraoperatively
Surgeon bleeding scale 0-3 for bleeding in the operative field
次要结局
- Patient Satisfaction(48 hours)
研究者
Elena Arnaoutoglou
Professor of Anesthesiology
University of Thessaly