CHINESE JOURNAL OF DRUG EVALUATION >

2025 , Vol. 42 >Issue 5: 384 - 384-388

DOI: https://doi.org/magtech-2025-09-19-00002

Propofol versus Fospropofol Disodium for Painless Gastrointestinal Endoscopy in Adults

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  • 1.Tai′an Maternal and Child Health Hospital， Shandong Tai′an 271000， China；
    2.The Second Affiliated Hospital of Shandong First Medical University， Shandong Tai′an 271000， China；
    3.The Second Traditional Chinese Medicine Hospital of Tai′an， Shandong Tai′an 271000， China

Received date: 2025-09-19

  Revised date: 2025-10-10

  Accepted date: 2025-11-27

  Online published: 2025-12-15

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Abstract

Objective： To compare the efficacy and safety of fospropofol disodium versus propofol for anesthesia in adult patients undergoing painless gastrointestinal endoscopy， focusing onthe potential of fospropofol disodium to reduce respiratory depression and injection pain， and to guide anesthetic selection in patients with differing risk profiles. Methods： In this randomized controlled trial， 80 adult patients (ASA physical status Ⅰ-Ⅱ) scheduled for painless gastrointestinal endoscopy between October 2023 and December 2024 were enrolled. They were randomly assigned via a computer-generated random number table to receive either propofol (Group A， n=40) or fospropofol disodium (Group B， n=40). We compared the procedure duration， recovery time， and time to discharge from the post-anesthesia care unit (PACU). Hemodynamic parameters， including blood pressure， heart rate， and oxygen saturation (SpO2)， were monitored at predefined time points. The incidence of adverse events such as hypotension， respiratory depression， and injection pain was recorded and statistically analyzed. Results： No significant intergroup difference was found in procedure duration (P>0.05). However， Group B exhibited significantly shorter recovery time and PACU discharge time than Group A (P<0.001). During anesthesia induction and maintenance (T1， T2， T3)， mean arterial pressure， heart rate levels were significantly higher in Group B (P<0.05). The incidence of hypotension， respiratory depression， and injection pain was significantly lower in Group B (P<0.05). In contrast， the rates of nausea and vomiting， bradycardia， and coughing did not differ significantly between groups (P>0.05). Further analysis indicated a number needed to treat (NNT) of 5 to prevent one case of respiratory depression， equating to approximately 200 fewer events per 1000 patients. Conclusion： Compared with propofol， fospropofol disodium provides superior hemodynamic stability and significantly reduces the incidence of respiratory depression and injection pain during painless gastrointestinal endoscopy in adults. Althoughit is particularly suitable for ASA Ⅰ-Ⅱ patients at risk of respiratory compromise， the final selection should be individualized based on patient characteristics and procedural requirements.

Key words： ; font-size:medium; ">Propofol； Fospropofol disodium； Painless gastrointestinal endoscopy； Randomized controlled trial

Cite this article

XU Chuangguo, YANG Pengpeng, CHEN Zhenjuan, ZHAO Xueliang . Propofol versus Fospropofol Disodium for Painless Gastrointestinal Endoscopy in Adults[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2025 , 42(5) : 384 -384-388 . DOI: magtech-2025-09-19-00002

References

 [1] Zhao Z， Jin X， Li Y， et al. Efficacy and safety of fospropofol disodium sedation for same-day bidirectional endoscopy in elderly patients： protocol for a prospective， single-center， randomized， double-blind， non-inferiority trial[J]. Front Pharmacol， 2024， 15：1378081
     [2] Wu CM， Zhang WS， Liu J， et al. Efficacy and safety of fospropofol disodium for injection in general anesthesia induction for adult patients： a phase 3 trial[J]. Front Pharmacol， 2021， 12： 687894.
     [3] Welliver M， Rugari SM. New drug， fospropfol disodium： a propofol prodrug[J]. AANA J， 2009， 77(4)：301-308.
     [4] Wehrmann T， Triantafyllou K. Propofol sedation in gastrointestinal endoscopy： a gastroenterologist′s perspective[J]. Digestion， 2010， 82(2)：106-100.
     [5] Wadhwa V， Issa D， Garg S， et al. Similar Risk of Cardiopulmonary Adverse Events Between Propofol and Traditional Anesthesia for Gastrointestinal Endoscopy： a systematic review and Meta-analysis[J]. Clin Gastroenterol Hepatol， 2016， 15(2)：194-206.
     [6] Sun H， Zhang L， Liu Z， et al. Study on different sequences of painless gastroenteroscopy in patients with difficult airway[J]. Biotechnol Genet Eng Rev， 2024， 40(2)： 1379-1388.
     [7] Stogiannou D， Protopapas A， et al. Is propofol the optimal sedative in gastrointestinal endoscopy[J]. Acta Gastroenterol Belg， 2019， 81(4)：520-524.
     [8] Sneyd JR. Making sense of propofol sedation for endoscopy[J]. Br J Anaesth， 2017， 118(1)：6-7.
     [9] 史春明. 丙泊酚用于无痛胃结肠镜检查后精神运动功能恢复质量的研究[J]. 北京大学学报（医学版）， 2023， 55(2)： 324-327.
     [10] Nelson DB， Barkun AN， Block KP， et al. Propofol use during gastrointestinal endoscopy[J]. Gastrointest Endosc， 2001， 53(7)：876-879.
     [11] Li A， Li N， Zhu L， et al. The efficacy and safety of ciprofol versus propofol in patients undergoing painless hysteroscopy： a randomized， double-blind， controlled trial[J]. BMC Anesthesiol， 2024， 24(1)：411.
     [12] Kyu LJ， Kee JD， Hee KW， et al. Safety of non-anesthesiologist administration of propofol for gastrointestinal endoscopy[J]. Korean J Gastroenterol， 2017， 69(1)：55.
     [13] Goudra B， Gouda G， Singh PM. Recent developments in drugs for GI endoscopy sedation [J]. Dig Dis Sci， 2020， 70(11)：65.
     [14] Garnock-Jones KP， Scott LJ. Fospropofol[J]. Drugs， 2010， 70(4：) 469-477.
     [15] Gao X. Fospropofol disodium versus propofol for long-term sedation during invasive mechanical ventilation： a pilot randomized clinical trial[J]. J Clin Anesth， 2024， 95： 111442.
     [16] Gao X. Fospropofol disodium for sedation of postoperative ICU patients： a dose-finding study[J]. Am J Ther， 31(4)： e435-e439.
     [17] Gao X， Gao C， Fang X， et al. Fospropofol disodium versus propofol for deep sedation in critically ill patients： a randomized pilot study[J]. BMC Anesthesiol， 2025， 25(1)：166.
     [18] Zhao Z， Jin X， Li Y， et al. Efficacy and safety of fospropofol disodium sedation for same-day bidirectional endoscopy in elderly patients： protocol for a prospective， single-center， randomized， double-blind， non-inferiority trial[J]. Front Pharmacol， 2024， 15：1378081.
     [19] Campion ME， Gan TJ. Fospropofol disodium for sedation[J]. Drugs Today， 2009， 45(8)：567-576.
     [20] Fechner J， Ihmsen H， Jeleazcov C， et al. Fospropofol disodium， a water-soluble prodrug of the intravenous anesthetic propofol (2， 6-diisopropylphenol) [J]. Expert Opin Investig Drugs， 2009， 18(10)：1565-1571.
     [21] Daza JF， Tan CM， Fielding RJ. Propofol administration by endoscopists versus anesthesiologists in gastrointestinal endoscopy： a systematic review and meta-analysis of patient safety outcomes[J]. Can J Surg， 61(4)：226-236.
     [22] Cohen LB， Cattau E， Goetsch A， et al. A randomized， double-blind， phase 3 study of fospropofol disodium for sedation during colonoscopy[J]. J Clin Gastroenterol， 2010， 44(5)：345-353.
     [23] Cohen LB. Clinical trial： a dose-response study of fospropofol disodium for moderate sedation during colonoscopy[J]. Aliment Pharmacol Ther， 2010， 27(7)：597-608.
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