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

NCT07788157 | Not Yet Recruiting DMC

• 1 other identifier: FDESS
• Study Type: interventional
• Target: 144
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endoscopic Sinus Surgery; Total Intravenous Anesthesia; Fospropofol Disodium

Outcome Measures

Primary Outcomes (2)

• The score of the Wormald scale

  The Wormald scales was used to assess the quality of the surgical field

  From the start of surgery to the end of surgery

• The score of the Boezaart scale

  The Boezaart scales was used to assess the quality of the surgical field

  From the start of surgery to the end of surgery

Secondary Outcomes (10)

• Total blood loss

  Perioperative

• The rate of bleeding

  Perioperative

• Induction time

  Perioperative

• Extubation time

  Perioperative

• Emergence time

  Perioperative

Study Arms (4)

Group P

ACTIVE COMPARATOR

Propofol induction (1-2 mg/kg) and propofol maintenance (5-12 mg/kg/h).

Drug: Propofol

Group F

EXPERIMENTAL

Fospropofol disodium induction (10-20 mg/kg) and fospropofol disodium maintenance (5-12 mg/kg/h).

Drug: Fospropofol disodium

Group PS

EXPERIMENTAL

Propofol induction (1-2 mg/kg) and maintenance with propofol plus sevoflurane (1.0%).

Drug: Propofol

Group FS

EXPERIMENTAL

Fospropofol disodium induction (10-20 mg/kg) and maintenance with fospropofol disodium plus sevoflurane (1.0%).

Drug: Fospropofol disodium

Interventions

Fospropofol disodium DRUG

Fospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.

Group F; Group FS

Propofol DRUG

Propofol induction and propofol maintenance with or without sevoflurane.

Group P; Group PS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

fospropofol; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Aijun Xu

CONTACT

027-83663423; ajxu@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share