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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Frontiers Media S.A.,
2024-08-01T00:00:00Z.
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001 | doaj_5b48997eaa3542bca19e5576d0ea0bf6 | ||
042 | |a dc | ||
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. |