drugset / Trial / NCT07788157

Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS

NCT07788157 ↗

Recruiting 144 enrolled Tongji Hospital
RandomizedParallel-groupDouble-blindOther

Summary

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.

Timeline

Start
2026-07-12
Primary completion
2026-09-30
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Propofol Small molecule 5 mg/kg Intravenous
Subject Propofol Small molecule 12 mg/kg Intravenous
Subject Sevoflurane Other / unclassified 1 % Inhaled
Subject fospropofol Small molecule 5 mg/kg Intravenous
Subject fospropofol Small molecule 12 mg/kg Intravenous

Indications

No indication recorded.