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 1:1 ratio, to a fospropofol group or a propofol group (n=128 in each group). All patients will receive analgesic pretreatment 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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
256
Fospropofol sedation for same-day bidirectional endoscopy in elderly patients
propofol
The success rate of same-day bidirectional endoscopy
The success rate of the gastrointestinal endoscopy was assessed according to the following criteria : 1) completion of the gastrointestinal endoscopy; 2) no need for rescue sedative/anesthetic, which means the top-up doses of the experimental drugs were administered no more than five times within any 15-min window from the initial administration to the end of the procedure.
Time frame: Immediate time after sedation emergence
The time to successful induction of sedation
the time counted from the start of drug administration to the achievement of a sedation score (MOAA/S ) ≤ 1
Time frame: Immediate time after sedation emergence
Time to being fully alert
the time from gastrointestinal endoscopy extraction or/and the time from the last drug administration to a MOAA/S score of 5 on three consecutive measurements;
Time frame: Immediate time after sedation emergence
Time to patient discharge
Time to patient discharge
Time frame: Immediate time of hospital discharge
Endoscopist's satisfaction questionnaire
Endoscopist's satisfaction
Time frame: Immediate time after sedation procedure completion
Patient's satisfaction questionnaire
Patient's satisfaction
Time frame: Immediate time of hospital discharge
The top-up frequency and dosage of sedative medications
The top-up frequency and dosage of sedative medications
Time frame: Immediate time after sedation emergence
Incidence of adverse events (AEs) at timepoint 1
Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Time frame: baseline (Prior to sedation)
Incidence of adverse events (AEs) at timepoint 2
Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Time frame: Intraoperative (during sedation)
Incidence of adverse events (AEs) at timepoint 3
Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Time frame: Intraoperative (the timepoint of sedation emergence)
Incidence of adverse events (AEs) at timepoint 4
Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Time frame: 15 min in post-anesthesia care unit
Incidence of adverse events (AEs) at timepoint 5
Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Time frame: 30 min in post-anesthesia care unit
Incidence of adverse events (AEs) at timepoint 6
Episodes of desaturation, severe desaturation (SpO2 \< 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Time frame: Immediate time of hospital discharge
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