{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T17:00:17Z","timestamp":1792688417734,"version":"4.5.0"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2021,9,13]],"date-time":"2021-09-13T00:00:00Z","timestamp":1631491200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:p><jats:bold>Background:<\/jats:bold>Fospropofol disodium for injection (Fospropofol<jats:sub>FD<\/jats:sub>) is a prodrug that is metabolized into propofol to produce a general anesthesia effect when administered intravenously.<\/jats:p><jats:p><jats:bold>Objective:<\/jats:bold>This study aimed to assess the efficacy and safety of Fospropofol<jats:sub>FD<\/jats:sub>in comparison with propofol medium\/long-chain fat emulsion injections (propofol-MCT\/LCT) for general anesthesia induction in adult patients undergoing elective surgeries.<\/jats:p><jats:p><jats:bold>Setting:<\/jats:bold>Nine academic medical centers in China.<\/jats:p><jats:p><jats:bold>Method:<\/jats:bold>This multicenter, randomized, double-blind, double-simulated, controlled, and non-inferiority trial evaluated 540 eligible adult patients randomly assigned (2:1) to the intervention (20\u00a0mg\/kg Fospropofol<jats:sub>FD<\/jats:sub>) or control (2\u00a0mg\/kg propofol-MCT\/LCT) groups.<\/jats:p><jats:p><jats:bold>Main Outcome Measure:<\/jats:bold>The primary efficacy endpoint was the success rate, defined as a Modified Observer\u2019s Assessment of Alertness\/Sedation Scale score of 1 within 5\u00a0min after study drug administration. The safety endpoints consisted of adverse events (AEs) related to consciousness, cognitive function, hemodynamic status, liver and kidney function, and blood tests.<\/jats:p><jats:p><jats:bold>Results:<\/jats:bold>A total of 347 (96.3%) and 175 (97.2%) patients in the intervention and control groups, respectively, completed the study. The success rate for the primary outcome was 97.7% for both study drugs. The most frequent AEs in the intervention group were abnormal feeling (62.0%), blood pressure reduction (13.5%), and injection site pain (13.3%). No AEs related to consciousness and mental and cognitive functions or serious adverse events were reported.<\/jats:p><jats:p><jats:bold>Conclusion:<\/jats:bold>Fospropofol<jats:sub>FD<\/jats:sub>(20\u00a0mg\/kg) is not inferior to propofol-MCT\/LCT (2\u00a0mg\/kg) in general anesthesia induction for American Society of Anesthesiologists (ASA) physical status I-II adult patients undergoing elective surgeries. It is safe and effective for clinical use under anesthesiologist monitoring.<\/jats:p><jats:p><jats:bold>Impact on Practice Statement:<\/jats:bold>Fospropofol<jats:sub>FD<\/jats:sub>can produce a general anesthesia effect and reduce the incidence of pain at the site of injection.<\/jats:p>","DOI":"10.3389\/fphar.2021.687894","type":"journal-article","created":{"date-parts":[[2021,9,13]],"date-time":"2021-09-13T05:37:42Z","timestamp":1631511462000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":20,"title":["Efficacy and Safety of Fospropofol Disodium for Injection in General Anesthesia Induction for Adult Patients: A Phase 3 Trial"],"prefix":"10.3389","volume":"12","author":[{"given":"Chao-Meng","family":"Wu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-Sheng","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei-Yi","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bo-Wen","family":"Ke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2021,9,13]]},"reference":[{"key":"B2","doi-asserted-by":"crossref","first-page":"79","DOI":"10.4103\/0970-9185.76656","article-title":"Fospropofol: Clinical Pharmacology","volume":"27","author":"Bengalorkar","year":"2011","journal-title":"J. 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