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

NCT06251999 | Not Yet Recruiting Phase 4

• 1 other identifier: XWANG
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

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

Keywords

fospropofol; propofol; sedation; elderly; bidirectional endoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediate time after sedation emergence

Secondary Outcomes (12)

• The time to successful induction of sedation

  Immediate time after sedation emergence

• Time to being fully alert

  Immediate time after sedation emergence

• Time to patient discharge

  Immediate time of hospital discharge

• Endoscopist's satisfaction questionnaire

  Immediate time after sedation procedure completion

• Patient's satisfaction questionnaire

  Immediate time of hospital discharge

Study Arms (2)

fospropofol

EXPERIMENTAL

Drug: fospropofol sedation

propofol

PLACEBO COMPARATOR

Drug: Propofol

Interventions

fospropofol sedation DRUG

Fospropofol sedation for same-day bidirectional endoscopy in elderly patients

fospropofol

Propofol DRUG

propofol

propofol

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: February 9, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share