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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Tongji Hospital • ClinicalTrials.gov ID: NCT07788157

Registry updated: 2026-09-17
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Description

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.

Interventions

  • Fospropofol disodium (Drug)
    Fospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.
  • Propofol (Drug)
    Propofol induction and propofol maintenance with or without sevoflurane.

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Conditions

Fospropofol Disodium

Locations

  • Tongji Hospital — Wuhan, Hubei, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record