Academic Journal
Evaluating sedation efficacy and perioperative safety of fospropofol disodium versus propofol in elderly patients undergoing elective TURP: study protocol for a randomized controlled trial.
| Τίτλος: | Evaluating sedation efficacy and perioperative safety of fospropofol disodium versus propofol in elderly patients undergoing elective TURP: study protocol for a randomized controlled trial. |
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| Συγγραφείς: | Sui H; Department of Anaesthesiology, The Second Hospital of Jiaxing, Second Affiliated Hospital of JiaXing University, 1518 Huancheng North Road, Nanhu District, Jiaxing City, Zhejiang Province, 314001, China., Wu T; Department of Anaesthesiology, The First Hospital of Jiaxing, Affiliated Hospital of JiaXing University, 1882 Zhonghuan South Road, Jiaxing City, Zhejiang Province, 314001, China., Gao L; Department of Anaesthesiology, The Second Hospital of Jiaxing, Second Affiliated Hospital of JiaXing University, 1518 Huancheng North Road, Nanhu District, Jiaxing City, Zhejiang Province, 314001, China., He Q; Department of Anaesthesiology, The Second Hospital of Jiaxing, Second Affiliated Hospital of JiaXing University, 1518 Huancheng North Road, Nanhu District, Jiaxing City, Zhejiang Province, 314001, China., Fan J; Department of Anesthesiology, Women and Children's Hospital of Jiaxing University, 2468 East Huancheng Road, Nanhu District, Jiaxing City, Zhejiang Province, 314001, China. 254602480@qq.com., Li Q; Department of Anaesthesiology, The Second Hospital of Jiaxing, Second Affiliated Hospital of JiaXing University, 1518 Huancheng North Road, Nanhu District, Jiaxing City, Zhejiang Province, 314001, China. Liqi77fyx@163.com. |
| Πηγή: | Trials [Trials] 2026 Aug 24; Vol. 27 (1). Date of Electronic Publication: 2026 Aug 24. |
| Τύπος έκδοσης: | Journal Article; Clinical Trial Protocol |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| Ιατρικοί όροι (MeSH): | Propofol*/analogs & derivatives , Propofol*/adverse effects , Propofol*/administration & dosage , Anesthetics, Intravenous*/adverse effects , Anesthetics, Intravenous*/administration & dosage , Transurethral Resection of Prostate*/adverse effects , Anesthesia, General*/methods , Anesthesia, General*/adverse effects , Hypnotics and Sedatives*/adverse effects , Hypnotics and Sedatives*/administration & dosage, Consciousness/drug effects ; Humans ; Male ; Aged ; Aged, 80 and over ; Elective Surgical Procedures ; Geriatric Anesthesia ; Treatment Outcome ; Randomized Controlled Trials as Topic ; Age Factors ; Time Factors ; China |
| Περίληψη: | Background: Fospropofol disodium is the first novel water-soluble propofol prodrug in China. After administration, it is mainly converted to propofol by alkaline phosphatase on the surface of endothelial cells to exert its pharmacological effects. Compared with propofol, fospropofol disodium has the characteristics of longer duration of action, lower incidence of injection pain and adverse events related to the respiratory and circulatory systems, and no adverse reactions related to lipid metabolism. At present, there are few reports on the safety and efficacy of fospropofol disodium in the induction and maintenance of general anesthesia. Therefore, this study aims to evaluate the safety and efficacy of fospropofol disodium in routine anesthesia for elective surgery in the elderly, so as to provide new medication guidance for its application in the induction and maintenance stages of general anesthesia in the elderly population. Methods: Seventy elderly patients aged 65-85 years with American Society of Anesthesiologists (ASA) physical status II or III, scheduled for elective transurethral resection of the prostate under general anesthesia, will be enrolled. Patients will be randomly divided into the propofol group (group E) and the fospropofol disodium group (group F) using a random number table, with 35 cases in each group. Anesthesia induction: sufentanil 0.2-0.4 µg/kg and cisatracurium besilate 0.15 mg/kg will be administered intravenously. Group E will receive an intravenous bolus of propofol 1-1.5 mg/kg, while group F will receive an intravenous bolus of fospropofol disodium 10-15 mg/kg, both infused within 60 s. Tracheal intubation will be performed when the patient's Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score decreases to 1 with BIS < 60 sustained for ≥3 min, followed by routine mechanical ventilation. For anesthesia maintenance, group E will receive continuous intravenous infusion of propofol 4-12 mg/(kg·h) and remifentanil 0.2-0.4 µg/(kg·min) via a syringe pump; group F will receive continuous intravenous infusion of fospropofol disodium 10-20 mg/(kg·h) and remifentanil 0.2-0.4 µg/(kg·min) via a syringe pump. During the operation, the infusion rates of maintenance anesthetics will be adjusted according to hemodynamic status to maintain blood pressure and heart rate fluctuations within 20% of the baseline values, and the Bispectral Index (BIS) value will be maintained between 40 and 60. After the operation, patients will be transferred to the post-anesthesia care unit (PACU). Primary outcomes of this study: success rate of sedation and time to onset of sedation. Secondary Outcomes: (1) perioperative indicators, (2) hemodynamic indices at each time point, (3) adverse reactions. Discussion: Elderly patients undergoing transurethral resection of the prostate (TURP) are often complicated with multiple comorbidities, leading to a relatively high anesthetic risk. This trial takes the success rate of sedation and time to onset of sedation as the primary endpoints, to compare the application differences between fospropofol disodium and propofol. The aim of this study is to evaluate the safety and efficacy of fospropofol disodium in routine anesthesia for elective surgeries in the elderly population. Trial Registration: The study was registered at the Chinese Clinical Trials Registry (ChiCTR2500115343) on December 24, 2025 ( http://www.chictr.org.cn/showproj.html?proj=294899 ). (© 2026. The Author(s).) |
| Competing Interests: | Declarations. Ethics approval and consent to participate {30}: This study protocol has been reviewed and approved by the Institutional Review Board (IRB) of Jiaxing Second Hospital (approval no.: JX2H-IRB-2025-177; approval date: August 5, 2025). The study will be conducted in accordance with the Declaration of Helsinki (2013 revision) and relevant national ethical guidelines for clinical research involving human subjects. Written informed consent will be obtained from all participants or their legal representatives prior to enrollment. The informed consent form will clearly explain the study purpose, procedures, potential risks, benefits, and the right to withdraw from the study at any time without prejudice to subsequent medical treatment. Consent for publication: Separate informed consent for the publication of trial results has been obtained from all participants during the trial enrollment process. This consent specifically covers the publication of de-identified trial data and research findings in peer-reviewed academic journals, conference presentations, and other academic dissemination channels. Competing interests {7b}: The authors declare no competing interests. |
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| Contributed Indexing: | Keywords: Fospropofol disodium; General anesthesia; Propofol; Transurethral resection of the prostate (TURP) |
| Substance Nomenclature: | YI7VU623SF (Propofol) LZ257RZP7K (fospropofol) 0 (Anesthetics, Intravenous) 0 (Hypnotics and Sedatives) |
| Entry Date(s): | Date Created: 20261014 Date Completed: 20261014 Latest Revision: 20261015 |
| Update Code: | 20261016 |
| PubMed Central ID: | PMC13660162 |
| DOI: | 10.1186/s13063-026-09957-0 |
| PMID: | 42870298 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1745-6215 |
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| DOI: | 10.1186/s13063-026-09957-0 |