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临床试验/NCT07788157
NCT07788157尚未招募不适用

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

Tongji Hospital0 个研究点目标入组 144 人开始时间: 2026年8月1日最近更新:
适应症
相关药物

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

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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

aijun xu

Professor

Tongji Hospital

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