Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251999
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-21
Brief Title:
Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients
Sponsor:
Shanghai 6th Peoples Hospital
Organization:
Shanghai 6th Peoples Hospital
Study Overview
Official Title:
Efficacy and Safety of Fospropofol Disodium Sedation for Same-day Bidirectional Endoscopy in Elderly Patients a Prospective Single-center Randomized Double-blind Non-inferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction Fospropofol disodium is a novel prodrug that has improved pharmacokinetic and pharmacodynamic properties 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 analysis This is a prospective single-center double-blind randomized propofol-controlled non-inferiority trial A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated in a 11 ratio to a fospropofol group or a propofol group n128 in each group All patients will receive analgesic pretreatment with sufentanil 5 μg Two minutes later an initial bolus dose of fospropofol 65 mgkg or 15 mgkg propofol and supplemental doses of fospropofol 16 mgkg or 05 mgkg propofol will be titrated as needed to the 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 AEs concerning cough reflex gag reflexes body movement muscular tremor pain on injection Sedation-related AEs including episodes of desaturation severe desaturation SpO2 90 hypotension severe hypotension decrease in mean blood pressure 30 of baseline and bradycardia will be also recorded Data will be analyzed on the intention-to-treat basis
Discussion The investigators 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 The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients
Methods and analysis This is a prospective single-center double-blind randomized propofol-controlled non-inferiority trial A total of 256 adult patients scheduled for same-day bidirectional endoscopy under sedation will be randomly allocated in a 11 ratio to a fospropofol group or a propofol group n128 in each group All patients will receive analgesic pretreatment with sufentanil 5 μg Two minutes later an initial bolus dose of fospropofol 65 mgkg or 15 mgkg propofol and supplemental doses of fospropofol 16 mgkg or 05 mgkg propofol will be titrated as needed to the 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 AEs concerning cough reflex gag reflexes body movement muscular tremor pain on injection Sedation-related AEs including episodes of desaturation severe desaturation SpO2 90 hypotension severe hypotension decrease in mean blood pressure 30 of baseline and bradycardia will be also recorded Data will be analyzed on the intention-to-treat basis
Discussion The investigators 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 The findings will provide daily practice of sedation regimens for same-day bidirectional endoscopy in elderly patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None