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NCT Number: NCT07788157

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. The score of the Wormald scale

    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

  2. The score of the Boezaart scale

    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

Secondary outcomes

  1. Total blood loss

    Time frame: Perioperative

    Total fluid volume in the suction canister at the end of surgery minus the total irrigation volume during surgery

  2. The rate of bleeding

    Time frame: Perioperative

    Total blood loss divided by surgical duration

  3. Induction time

    Time frame: Perioperative

    From the start of anesthesia to loss of consciousness

  4. Extubation time

    Time frame: Perioperative

    From the end of anesthesia to extubation

  5. Emergence time

    Time frame: Perioperative

    From the end of anesthesia to recovery of consciousness

  6. PACU length of stay

    Time frame: Perioperative

    From admission to the PACU until meeting discharge criteria

  7. Emergence agitation

    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).

  8. Postoperative pain score

    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).

  9. Postoperative nausea and vomiting (PONV)

    Time frame: Perioperative

    Use a questionnaire to assess the incidence of postoperative nausea and vomiting.

  10. Postoperative sleep quality

    Time frame: Perioperative

    Use a questionnaire to assess the quality of postoperative sleep

Study contacts

Contact information is provided by the study sponsor or research team.

Aijun Xu

CONTACT

[email protected]

027-83663423

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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