Fospropofol Disodium
Conditions
Brief 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.
Interventions
Fospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.
DRUGPropofol
Propofol induction and propofol maintenance with or without sevoflurane.
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The score of the Wormald scale | From the start of surgery to the end of surgery | 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 | From the start of surgery to the end of surgery | The Boezaart scales was used to assess the quality of the surgical field, 0-5 points, with higher scores indicating worse visual field. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss | Perioperative | Total fluid volume in the suction canister at the end of surgery minus the total irrigation volume during surgery |
| The rate of bleeding | Perioperative | Total blood loss divided by surgical duration |
| Induction time | Perioperative | From the start of anesthesia to loss of consciousness |
| Extubation time | Perioperative | From the end of anesthesia to extubation |
| Emergence time | Perioperative | From the end of anesthesia to recovery of consciousness |
| PACU length of stay | Perioperative | From admission to the PACU until meeting discharge criteria |
| Emergence agitation | 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). |
| Postoperative pain score | 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). |
| Postoperative nausea and vomiting (PONV) | Perioperative | Use a questionnaire to assess the incidence of postoperative nausea and vomiting. |
Countries
China
Contacts
CONTACTAijun Xu, Dr
STUDY_DIRECTORAihua Du, Dr
Tongji Hospital
Outcome results
None listed