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

NCT ID: NCT06251999

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2028-08-31

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 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.

Conditions

Elderly Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

fospropofol

Group Type: EXPERIMENTAL

fospropofol sedation

Intervention Type: DRUG

Fospropofol sedation for same-day bidirectional endoscopy in elderly patients

propofol

Group Type: PLACEBO_COMPARATOR

Propofol

Intervention Type: DRUG

propofol

Interventions

fospropofol sedation

Fospropofol sedation for same-day bidirectional endoscopy in elderly patients

Intervention Type: DRUG

Propofol

propofol

Intervention Type: DRUG

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaofeng WANG

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

XWANG

Identifier Type: -

Identifier Source: org_study_id