Influence of Propofol Versus Sevoflurane on Surgical Conditions During Functional Endoscopic Sinus Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Boezaart surgical grading scale
研究概览
简要总结
Good surgical conditions are crucial for an optimal surgery result and safe procedure. Minimal blood loss in the surgical field is one of the most important conditions to maintain a good visualization, especially in surgeries with a small surgical field such as a FESS (functional endoscopic sinus surgery). The perioperative blood loss is determined by the main arterial and venous pressure, the local pressure and the capillary vascular filling pressure.
It has been proposed that propofol is a venodilator, which increases the blood flow, but decreases the capillary pressure. On the contrary, sevoflurane might act mainly on the arterioles, which causes an increase in the capillary pressure. In a previous study it has been demonstrated that despite blood pressure maintenance, propofol causes less bleeding during spinal surgery than sevoflurane.
The main aim of this study was to compare both anaesthetics on the perioperative bleeding and haemodynamics during FESS. Secondary, the postoperative nausea, vomiting, pain scores, surgery duration and length of stay at the post-anesthesia care unit will be evaluated.
详细描述
2 X 30 patients which are planned for FESS surgery are randomized in a sevoflurane group or propofol group.
All patients will be induced with propofol (target-controlled infusion (TCI) 4 µg/mL) and remifentanil (TCI 4 ng/mL) and receive a multimodal intravenous analgesia.
Patients in the propofol group will receive further intravenous propofol until a bispectral index (BIS) value of 50 is reached.
The intravenous drip of propofol will be stopped after induction in the sevoflurane group and patients will receive sevoflurane as inhalation anaesthetic (1 MAC) until a BIS-value of 50. The surgeon will be blinded for patient allocation.
The surgical conditions will be graded postoperatively by the surgeon who performed the operation using the validated Boezaart grading scale. The endoscopic images will be evaluated in addition by 3 blinded surgeons using this same scale.
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
- Double (Participant, Care Provider)
盲法说明
The surgeon and participant are blinded for randomization. The anesthesiologist is unblinded.
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
- •patient planned for FESS surgery
排除标准
- •patients which receive anticoagulants
- •patients which have coagulation disorders
- •patients with high bleeding risk
- •patients with arterial hypertension
- •other decided by surgeon
研究组 & 干预措施
sevoflurane
干预措施: Sevoflurane (Drug)
propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Boezaart surgical grading scale
时间窗: during surgery
Evaluation of surgical conditions by determination of the validated Boezaart surgical grading scale. Score 0 (no bleeding) to 5 (severe bleeding) The scale will be determined by the operating surgeon and 3 independent surgeons based on an endoscopic video recording.
次要结局
- Surgery duration(Immediately after surgery)
- Postoperative pain scores(in the first 48 hours after surgery)
- Arterial blood pressure(During surgery)
- Length of stay on the PACU(From arrival on the PACU until achievement of the PACU discharge criteria)
- PONV scores(In the first 48 hours after surgery)
研究者
Dr. Alain Kalmar, MD, PhD
Staff Anesthesist
Algemeen Ziekenhuis Maria Middelares