Effects of Fospropofol Disodium-Based Total Intravenous Anesthesia and Intravenous-Inhalation Combined Anesthesia on Surgical Field Quality in Adult Endoscopic Sinus Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- The score of the Wormald scale
研究概览
简要总结
Endoscopic sinus surgery (ESS) is a primary surgical approach for treating chronic rhinosinusitis, nasal polyps, and other conditions that are unresponsive to conservative therapy. A clear surgical field is a critical prerequisite for ensuring precision, efficiency, and the avoidance of injury to vital structures such as the orbit and the skull base. Currently, the anesthetic regimens commonly used for ESS include total intravenous anesthesia (TIVA), inhalational anesthesia (IA), and intravenous-inhalational combined anesthesia (IVIH). However, there remains controversy regarding the comparative effects of these three modalities on surgical field quality. IVIH, as an anesthetic strategy that integrates the advantages of both intravenous and inhalational agents, is widely employed in clinical practice. In the context of ESS, it may reduce the dose of individual agents through combination therapy, thereby minimizing dose-related adverse effects. Some studies have shown that propofol-based TIVA provides better surgical field conditions than inhalational anesthetics (e.g., desflurane, sevoflurane), but does not significantly reduce total blood loss or shorten operative time. Nevertheless, propofol is associated with drawbacks such as injection pain and propofol infusion syndrome. Fospropofol disodium, a water-soluble prodrug of propofol, offers a significant advantage in reducing injection pain and provides more stable hemodynamic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •age 18-65 years
- •ASA physical status I-II
- •BMI 18-35 kg/m²
- •diagnosed with chronic rhinosinusitis (with or without nasal polyps) and scheduled for elective endoscopic sinus surgery
- •provided written informed consent
排除标准
- •uncontrolled hypertension or asthma
- •use of medications that may affect coagulation function (e.g., NSAIDs) within 1 week prior to surgery
- •pre-existing coagulation abnormalities
- •history of bleeding disorders
- •history of drug allergy (to propofol, fospropofol disodium, or sevoflurane)
- •other comorbidities, such as uncorrected congenital heart disease, neuromuscular disorders, or hepatic/renal dysfunction
- •recent participation in other clinical studies
结局指标
主要结局
The score of the Wormald scale
时间窗: From the start of surgery to the end of surgery
The Wormald scales was used to assess the quality of the surgical field
The score of the Boezaart scale
时间窗: From the start of surgery to the end of surgery
The Boezaart scales was used to assess the quality of the surgical field
次要结局
- Total blood loss(Perioperative)
- The rate of bleeding(Perioperative)
- Induction time(Perioperative)
- Extubation time(Perioperative)
- Emergence time(Perioperative)
- PACU length of stay(Perioperative)
- Emergence agitation(Perioperative)
- Postoperative pain score(Perioperative)
- Postoperative nausea and vomiting (PONV)(Perioperative)
- Postoperative sleep quality(Perioperative)
