Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fospropofol sedation, Propofol.
- Who it may be relevant to
- Registry conditions: Elderly Patients. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug fospropofol sedation
Fospropofol sedation for same-day bidirectional endoscopy in elderly patients - Drug Propofol
propofol
Primary outcome measures
- The success rate of same-day bidirectional endoscopy [Time frame: Immediate time after sedation emergence]
Secondary outcome measures (12)
- The time to successful induction of sedation [Time frame: Immediate time after sedation emergence]
- Time to being fully alert [Time frame: Immediate time after sedation emergence]
- Time to patient discharge [Time frame: Immediate time of hospital discharge]
- Endoscopist's satisfaction questionnaire [Time frame: Immediate time after sedation procedure completion]
- Patient's satisfaction questionnaire [Time frame: Immediate time of hospital discharge]
- The top-up frequency and dosage of sedative medications [Time frame: Immediate time after sedation emergence]
- Incidence of adverse events (AEs) at timepoint 1 [Time frame: baseline (Prior to sedation)]
- Incidence of adverse events (AEs) at timepoint 2 [Time frame: Intraoperative (during sedation)]
- Incidence of adverse events (AEs) at timepoint 3 [Time frame: Intraoperative (the timepoint of sedation emergence)]
- Incidence of adverse events (AEs) at timepoint 4 [Time frame: 15 min in post-anesthesia care unit]
- Incidence of adverse events (AEs) at timepoint 5 [Time frame: 30 min in post-anesthesia care unit]
- Incidence of adverse events (AEs) at timepoint 6 [Time frame: Immediate time of hospital discharge]
Eligibility criteria
Inclusion criteria
- 65 years or older
- American Society of Anesthesiologists (ASA) physical status I to III
- Body mass index (BMI) 18-30 kg/m2
- Scheduled for same-day bidirectional endoscopy under sedation
Exclusion criteria
- Severe cardiovascular, pulmonary, renal, or liver diseases
- Previous hypotension (systolic blood pressure ≤90 mmHg), bradycardia (heart rate <50 beats/min), or hypoxemia (SpO2 <90%)
- Neurocognitive or psychiatric disorders
- Contraindications to gastroscopy (gastric retention, long-term aspirin administration, etc.)
- Hypersensitivity to study medications
- Drug or alcohol misuse
- Definite upper respiratory tract infection
- Refusal for participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06251999 · XWANG