ClinicalTrials.gg
RecruitingNCT07788157Updated Nov 3, 2026

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

An interventional study of Fospropofol disodium and Propofol in Fospropofol Disodium, sponsored by Tongji Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Tongji Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Nov 3, 2026Primary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fospropofol Disodium
03

In context

Lead sponsor

Tongji Hospital is the lead sponsor of 386 studies on the registry; 209 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age 18-65 years
  • I-II
  • 18-35 kg/m²
  • diagnosed with chronic rhinosinusitis (with or without nasal polyps) and scheduled for elective endoscopic sinus surgery
  • provided written

Exclusion criteria

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
144 participants (estimated)

Study arms

  • Active comparator
    Group P

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

    Drug: Propofol

  • Experimental
    Group F

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

    Drug: Fospropofol disodium

  • Experimental
    Group PS

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

    Drug: Propofol

  • Experimental
    Group FS

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

    Drug: Fospropofol disodium

Interventions

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

  • Propofol induction and propofol maintenance with or without sevoflurane.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From the start of surgery to the end of surgery

  2. 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.

    Time frame: From the start of surgery to the end of surgery

Secondary outcomes

  1. Total blood loss

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

    Time frame: Perioperative

  2. The rate of bleeding

    Total blood loss divided by surgical duration

    Time frame: Perioperative

  3. Induction time

    From the start of anesthesia to loss of consciousness

    Time frame: Perioperative

  4. Extubation time

    From the end of anesthesia to extubation

    Time frame: Perioperative

  5. Emergence time

    From the end of anesthesia to recovery of consciousness

    Time frame: Perioperative

  6. PACU length of stay

    From admission to the PACU until meeting discharge criteria

    Time frame: Perioperative

  7. Emergence agitation

    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

  8. Postoperative pain score

    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

  9. Postoperative nausea and vomiting (PONV)

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

    Time frame: Perioperative

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Sep 30, 2026→Dec 30, 2026
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Primary completion Sep 30, 2026→Dec 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07788157
Lead sponsor
Tongji Hospital
Responsible party
aijun xu (Professor, Tongji Hospital) — Principal investigator
First posted
Aug 26, 2026
Start date
Jul 12, 2026
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 3, 2026

Study contacts

Aijun Xu, Dr
Contact
ajxu@tjh.tjmu.edu.cn
027-83663423
Aihua Du, Dr
study director · Tongji Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Fospropofol · Propofol

Start the discussion