About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Fospropofol disodium
DrugFospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.
Propofol
DrugPropofol induction and propofol maintenance with or without sevoflurane.
Treatment groups
Trial outcomes
Primary outcomes
The score of the Wormald scale
The Wormald scales was used to assess the quality of the surgical field, 0-10 points, with higher scores indicating worse visual field.
The score of the Boezaart scale
The Boezaart scales was used to assess the quality of the surgical field, 0-5 points, with higher scores indicating worse visual field.
Secondary outcomes
Total blood loss
Total fluid volume in the suction canister at the end of surgery minus the total irrigation volume during surgery
The rate of bleeding
Total blood loss divided by surgical duration
Induction time
From the start of anesthesia to loss of consciousness
Extubation time
From the end of anesthesia to extubation
Sponsors and contacts
Click on the lead sponsor to view all of their trials.