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

IntroductionFospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties when compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients.Method...

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Main Authors: Zhe Zhao (Author), Xiaogao Jin (Author), Yong Li (Author), Xiaofeng Wang (Author), Yongchen Cui (Author), Bing Zhang (Author), Yu Kang (Author), Guangming Zhang (Author), Qinjun Chu (Author), Junfeng Zhang (Author)
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Published: Frontiers Media S.A., 2024-08-01T00:00:00Z.
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100 1 0 |a Zhe Zhao  |e author 
700 1 0 |a Xiaogao Jin  |e author 
700 1 0 |a Yong Li  |e author 
700 1 0 |a Xiaofeng Wang  |e author 
700 1 0 |a Yongchen Cui  |e author 
700 1 0 |a Bing Zhang  |e author 
700 1 0 |a Yu Kang  |e author 
700 1 0 |a Guangming Zhang  |e author 
700 1 0 |a Qinjun Chu  |e author 
700 1 0 |a Junfeng Zhang  |e author 
245 0 0 |a 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 
260 |b Frontiers Media S.A.,   |c 2024-08-01T00:00:00Z. 
500 |a 1663-9812 
500 |a 10.3389/fphar.2024.1378081 
520 |a IntroductionFospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties when compared with propofol. This trial aims to compare the efficacy and safety of fospropofol versus propofol sedation for same-day bidirectional endoscopy in elderly patients.Methods and analysisThis is a prospective, single-center, double-blind, randomized, propofol-controlled, non-inferiority trial. A total of 256 patients aged 65 years or older, who are scheduled for same-day bidirectional endoscopy under sedation, will be randomly allocated, in a 1:1 ratio, to either fospropofol group or propofol group (n = 128 in each group). All patients will receive analgesic pre-treatment with sufentanil 5 μg. Two minutes later, an initial bolus dose of fospropofol 6.5 mg/kg or 1.5 mg/kg propofol and supplemental doses of fospropofol 1.6 mg/kg or 0.5 mg/kg propofol will be titrated as needed to achieve target sedation levels during the procedures. The primary outcome is the success rate of same-day bidirectional endoscopy. Secondary outcomes include the time to successful induction of sedation, duration, time to being fully alert, time to patient discharge, endoscopist satisfaction, patient satisfaction, and the top-up frequency and dosage of sedative medications. The safety endpoints consist of adverse events concerning cough reflex, gag reflexes, body movement, muscular tremor, and pain on injection. Sedation-related AEs, including episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in MBP ≥30% of baseline), and bradycardia, will also be recorded. Data will be analyzed on an intention-to-treat basis.DiscussionWe hypothesize that the efficacy and safety of fospropofol sedation for elderly patients undergoing same-visit bidirectional endoscopy will not be inferior to that of propofol. Our findings will potentially provide a new sedation regimen for same-visit bidirectional endoscopy in elderly patients.Clinical Trial Registrationclinicaltrials.gov, identifier NCT02875639 
546 |a EN 
690 |a fospropofol 
690 |a propofol 
690 |a sedation 
690 |a elderly 
690 |a bidirectional endoscopy 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
655 7 |a article  |2 local 
786 0 |n Frontiers in Pharmacology, Vol 15 (2024) 
787 0 |n https://www.frontiersin.org/articles/10.3389/fphar.2024.1378081/full 
787 0 |n https://doaj.org/toc/1663-9812 
856 4 1 |u https://doaj.org/article/5b48997eaa3542bca19e5576d0ea0bf6  |z Connect to this object online.