Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients

Shanghai Jiao Tong University

Status and phase

Not yet enrolling

Phase 4

Conditions

Elderly Patients

Treatments

Drug: Propofol

Drug: fospropofol sedation

Study type

Interventional

Funder types

Other

Identifiers

NCT06251999

XWANG

Details and patient eligibility

About

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.

Enrollment

256 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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