Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS
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
Run by Tongji Hospital · NCT07788157 · Data updated 2026-11-12
This study tests fospropofol disodium–based anesthesia options to see which provides the clearest surgical field during endoscopic sinus surgery in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | July 12, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07788157 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-65 with chronic rhinosinusitis undergoing elective ESS and ASA I-II, able to provide informed consent.
✕Probably not a fit
Patients with uncontrolled hypertension or asthma, coagulation disorders, significant organ dysfunction, or recent participation in other trials may not benefit and could be excluded or experience limited utility.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares different anesthesia regimens—total intravenous anesthesia, inhalational anesthesia, and combined intravenous-inhalational anesthesia—using fospropofol disodium and propofol to determine their effect on surgical field quality during elective endoscopic sinus surgery in adults with chronic rhinosinusitis. Eligible participants are adults aged 18 to 65 with ASA I-II status, undergoing ESS for chronic rhinosinusitis with or without nasal polyps. The trial likely analyzes intraoperative field clarity, dosing, and safety parameters to identify potential advantages or trade-offs among regimens. It is conducted at Tongji Hospital in Wuhan, with Fospropofol disodium and propofol as interventions, and excludes individuals with significant comorbidities or coagulation-related risks. The lead sponsor is Tongji Hospital, and no collaborators are listed.
Why it matters
Potential benefit: If successful, the study could identify anesthesia approaches that improve surgical field visibility and potentially reduce adverse events during ESS.
How similar studies have gone: Previous work in anesthesia for ESS has explored IV, IA, and IVIH strategies, but direct comparisons with fospropofol disodium–based regimens remain limited, making this approach relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Tongji Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Aijun Xu, Dr
- Email: ajxu@tjh.tjmu.edu.cn
- Phone: 027-83663423
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.