A Phase 4 interventional study of fospropofol sedation and Propofol in Elderly Patients, sponsored by Shanghai 6th People's Hospital. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by Shanghai 6th People's Hospital · Phase 4, Interventional, and Treatment
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.
Shanghai 6th People's Hospital is the lead sponsor of 69 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
Drug: fospropofol sedation
Drug: Propofol
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
No study locations are listed for this record.
Plan to share: No
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Shanghai 6th People's Hospital