[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653583":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":45,"studyPopulation":45,"armGroups":54,"interventions":75,"overallOfficials":85,"centralContacts":89,"locations":95,"responsibleParty":114,"collaborators":45,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":45,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":45,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":45,"overallStatus":97,"whyStopped":45,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Tongji Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":45},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","From the start of surgery to the end of surgery",{"measure":14,"description":15,"timeFrame":12},"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.",[17,21,24,27,30,33,36,39,42],{"measure":18,"description":19,"timeFrame":20},"Total blood loss","Total fluid volume in the suction canister at the end of surgery minus the total irrigation volume during surgery","Perioperative",{"measure":22,"description":23,"timeFrame":20},"The rate of bleeding","Total blood loss divided by surgical duration",{"measure":25,"description":26,"timeFrame":20},"Induction time","From the start of anesthesia to loss of consciousness",{"measure":28,"description":29,"timeFrame":20},"Extubation time","From the end of anesthesia to extubation",{"measure":31,"description":32,"timeFrame":20},"Emergence time","From the end of anesthesia to recovery of consciousness",{"measure":34,"description":35,"timeFrame":20},"PACU length of stay","From admission to the PACU until meeting discharge criteria",{"measure":37,"description":38,"timeFrame":20},"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).",{"measure":40,"description":41,"timeFrame":20},"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).",{"measure":43,"description":44,"timeFrame":20},"Postoperative nausea and vomiting (PONV)","Use a questionnaire to assess the incidence of postoperative nausea and vomiting.",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":6,"observationalModel":45,"timePerspective":45,"maskingInfo":49},"RANDOMIZED","PARALLEL",{"masking":50,"maskingDescription":45,"whoMasked":51},"DOUBLE",[52,53],"PARTICIPANT","INVESTIGATOR",[55,61,67,71],{"label":56,"type":57,"description":58,"interventionNames":59},"Group P","ACTIVE_COMPARATOR","Propofol induction (1-2 mg\u002Fkg) and propofol maintenance (5-12 mg\u002Fkg\u002Fh).",[60],"Drug: Propofol",{"label":62,"type":63,"description":64,"interventionNames":65},"Group F","EXPERIMENTAL","Fospropofol disodium induction (10-20 mg\u002Fkg) and fospropofol disodium maintenance (5-12 mg\u002Fkg\u002Fh).",[66],"Drug: Fospropofol disodium",{"label":68,"type":63,"description":69,"interventionNames":70},"Group PS","Propofol induction (1-2 mg\u002Fkg) and maintenance with propofol plus sevoflurane (1.0%).",[60],{"label":72,"type":63,"description":73,"interventionNames":74},"Group FS","Fospropofol disodium induction (10-20 mg\u002Fkg) and maintenance with fospropofol disodium plus sevoflurane (1.0%).",[66],[76,81],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":45},"DRUG","Fospropofol disodium","Fospropofol disodium induction and fospropofol disodium maintenance with or without sevoflurane.",[62,72],{"type":77,"name":82,"description":83,"armGroupLabels":84,"otherNames":45},"Propofol","Propofol induction and propofol maintenance with or without sevoflurane.",[56,68],[86],{"name":87,"affiliation":5,"role":88},"Aihua Du, Dr","STUDY_DIRECTOR",[90],{"name":91,"role":92,"phone":93,"phoneExt":45,"email":94},"Aijun Xu, Dr","CONTACT","027-83663423","ajxu@tjh.tjmu.edu.cn",[96],{"facility":5,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":104,"coordinates":105},"Point",[106,107],114.26667,30.58333,{"lat":107,"lon":106},[110],{"name":111,"role":92,"phone":112,"phoneExt":45,"email":113},"Pu Zhou","02783663625","tongjihlunli@163.com",{"type":115,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","aijun xu","Professor","100653583","effects-of-fospropofol-disodium-tiva-and-ivih-on-surgical-field-quality-in-adult-ess-100653583",false,"NCT07788157","Effects of Fospropofol Disodium TIVA and IVIH on Surgical Field Quality in Adult ESS","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","Inclusion Criteria:\n\n* age 18-65 years\n* ASA physical status I-II\n* BMI 18-35 kg\u002Fm²\n* diagnosed with chronic rhinosinusitis (with or without nasal polyps) and scheduled for elective endoscopic sinus surgery\n* provided written informed consent\n\nExclusion Criteria:\n\n* uncontrolled hypertension or asthma\n* use of medications that may affect coagulation function (e.g., NSAIDs) within 1 week prior to surgery\n* pre-existing coagulation abnormalities\n* history of bleeding disorders\n* history of drug allergy (to propofol, fospropofol disodium, or sevoflurane)\n* other comorbidities, such as uncorrected congenital heart disease, neuromuscular disorders, or hepatic\u002Frenal dysfunction\n* recent participation in other clinical studies","ALL","18 Years","65 Years",{"count":129,"type":130},144,"ESTIMATED","INTERVENTIONAL",[133],"NA","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.",[136],"Fospropofol Disodium","2026-09-14",{"date":139,"type":140},"2026-09-17","ACTUAL",{"date":142,"type":140},"2026-07-12",{"date":144,"type":130},"2026-12-31",{"name":5,"class":6},1]