fospropofol disodium
DrugFospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.
NCT Number: NCT07788157
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.
Propofol induction and propofol maintenance with or without sevoflurane.
Time frame: From the start of surgery to the end of surgery
The Wormald scales was used to assess the quality of the surgical field
Time frame: From the start of surgery to the end of surgery
The Boezaart scales was used to assess the quality of the surgical field
Time frame: Perioperative
Total fluid volume in the suction canister at the end of surgery minus the total irrigation volume during surgery
Time frame: Perioperative
Total blood loss divided by surgical duration
Time frame: Perioperative
From the start of anesthesia to loss of consciousness
Time frame: Perioperative
From the end of anesthesia to extubation
Time frame: Perioperative
From the end of anesthesia to recovery of consciousness
Time frame: Perioperative
From admission to the PACU until meeting discharge criteria
Time frame: Perioperative
Emergence agitation was assessed using the Richmond Agitation-Sedation Scale (RASS), the range is between -5 and +4, higher scores mean a worse outcome in terms of sedation level (too agitated) and a worse outcome in terms of over-sedation (too deeply sedated).
Time frame: Perioperative
Postoperative pain score was assessed using the Visual Analogue Scale (VAS), the range is between 0-10, higher scores mean a worse outcome (indicating more severe pain).
Time frame: Perioperative
Use a questionnaire to assess the incidence of postoperative nausea and vomiting.
Time frame: Perioperative
Use a questionnaire to assess the quality of postoperative sleep
Contact information is provided by the study sponsor or research team.
Tongji Hospital
Other
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
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