Fospropofol DisodiumNCT07788157
Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
A study testing Fospropofol disodium and Propofol in people with Fospropofol Disodium, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fospropofol Disodium
- What is being tested?
- Fospropofol disodium and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Pu Zhou, 02783663625, tongjihlunli@163.com
About this study
Official 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
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
- Fospropofol Disodium
- Being tested
- Fospropofol disodium, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fospropofol disodiumDrug
Fospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.
PropofolDrug
Propofol induction and propofol maintenance with or without sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Propofol induction (1-2 mg/kg) and propofol maintenance (5-12 mg/kg/h). Receives: Drug: Propofol |
| Group F | Experimental | Fospropofol disodium induction (10-20 mg/kg) and fospropofol disodium maintenance (5-12 mg/kg/h). Receives: Drug: Fospropofol disodium |
| Group PS | Experimental | Propofol induction (1-2 mg/kg) and maintenance with propofol plus sevoflurane (1.0%). Receives: Drug: Propofol |
| Group FS | Experimental | Fospropofol disodium induction (10-20 mg/kg) and maintenance with fospropofol disodium plus sevoflurane (1.0%). Receives: Drug: Fospropofol disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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, 0-5 points, with higher scores indicating worse visual field.
Measured: From the start of surgery to the end of surgery
Secondary outcomes (9)
Total blood loss
Total fluid volume in the suction canister at the end of surgery minus the total irrigation volume during surgery
Measured: Perioperative
The rate of bleeding
Total blood loss divided by surgical duration
Measured: Perioperative
Induction time
From the start of anesthesia to loss of consciousness
Measured: Perioperative
Extubation time
From the end of anesthesia to extubation
Measured: Perioperative
Emergence time
From the end of anesthesia to recovery of consciousness
Measured: Perioperative
PACU length of stay
From admission to the PACU until meeting discharge criteria
Measured: Perioperative
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).
Measured: Perioperative
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).
Measured: Perioperative
Postoperative nausea and vomiting (PONV)
Use a questionnaire to assess the incidence of postoperative nausea and vomiting.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start12 Jul 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fospropofol DisodiumStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- Aihua Du, Dr, Study director, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788157
- Sponsor's protocol ID
- FDESS
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07788157
- Acronym / sponsor ID
- FDESS
- Conditions
- Fospropofol Disodium
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 12 Jul 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: PropofolPropofol induction (1-2 mg/kg) and propofol maintenance (5-12 mg/kg/h). |
| Group F | Experimental | Drug: Fospropofol disodiumFospropofol disodium induction (10-20 mg/kg) and fospropofol disodium maintenance (5-12 mg/kg/h). |
| Group PS | Experimental | Drug: PropofolPropofol induction (1-2 mg/kg) and maintenance with propofol plus sevoflurane (1.0%). |
| Group FS | Experimental | Drug: Fospropofol disodiumFospropofol disodium induction (10-20 mg/kg) and maintenance with fospropofol disodium plus sevoflurane (1.0%). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fospropofol disodiumFospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane. | Drug | Group F, Group FS |
| PropofolPropofol induction and propofol maintenance with or without sevoflurane. | Drug | Group P, Group PS |
Primary outcome
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, 0-10 points, with higher scores indicating worse visual field.
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, 0-5 points, with higher scores indicating worse visual field.
9 secondary outcomes
Total blood loss
Time frame: Perioperative
The rate of bleeding
Time frame: Perioperative
Induction time
Time frame: Perioperative
Extubation time
Time frame: Perioperative
Emergence time
Time frame: Perioperative
PACU length of stay
Time frame: Perioperative
Emergence agitation
Time frame: Perioperative
Postoperative pain score
Time frame: Perioperative
Postoperative nausea and vomiting (PONV)
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes
Related trials for Fospropofol Disodium
Not yet recruitingPhase 4
Fospropofol Disodium Versus Propofol for Patient Satisfaction in Ureteroscopy
Anesthesia for Urologic Endoscopic Surgery, Urinary Calculi
Not yet recruitingPhase 4
Fospropofol Disodium ED95 for Elderly Spinal Anesthesia Sedation
Lower Extremity Surgery
RecruitingPhase 4
Efficacy and Safety of Fospropofol in Adult Laparoscopic Surgery: A Clinical Trial
Drug Safety
Not yet recruitingPhase 4
Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients
Elderly Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aihua Du, Dr study director
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fospropofol disodium and Propofol in people with Fospropofol Disodium, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aijun Xu, Dr (027-83663423, ajxu@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score of the Wormald scale (time frame: From the start of surgery to the end of surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.