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

February 8, 2024 updated by: Xiaofeng WANG, Shanghai 6th People's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Interventional

Enrollment (Estimated)

256

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: propofol
propofol
Experimental: fospropofol
Fospropofol sedation for same-day bidirectional endoscopy in elderly patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The success rate of same-day bidirectional endoscopy
Time Frame: Immediate time after sedation emergence
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time to successful induction of sedation
Time Frame: Immediate time after sedation emergence
the time counted from the start of drug administration to the achievement of a sedation score (MOAA/S ) ≤ 1
Immediate time after sedation emergence
Time to being fully alert
Time Frame: Immediate time after sedation emergence
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;
Immediate time after sedation emergence
Time to patient discharge
Time Frame: Immediate time of hospital discharge
Time to patient discharge
Immediate time of hospital discharge
Endoscopist's satisfaction questionnaire
Time Frame: Immediate time after sedation procedure completion
Endoscopist's satisfaction
Immediate time after sedation procedure completion
Patient's satisfaction questionnaire
Time Frame: Immediate time of hospital discharge
Patient's satisfaction
Immediate time of hospital discharge
The top-up frequency and dosage of sedative medications
Time Frame: Immediate time after sedation emergence
The top-up frequency and dosage of sedative medications
Immediate time after sedation emergence
Incidence of adverse events (AEs) at timepoint 1
Time Frame: baseline (Prior to sedation)
Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
baseline (Prior to sedation)
Incidence of adverse events (AEs) at timepoint 2
Time Frame: Intraoperative (during sedation)
Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Intraoperative (during sedation)
Incidence of adverse events (AEs) at timepoint 3
Time Frame: Intraoperative (the timepoint of sedation emergence)
Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Intraoperative (the timepoint of sedation emergence)
Incidence of adverse events (AEs) at timepoint 4
Time Frame: 15 min in post-anesthesia care unit
Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
15 min in post-anesthesia care unit
Incidence of adverse events (AEs) at timepoint 5
Time Frame: 30 min in post-anesthesia care unit
Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
30 min in post-anesthesia care unit
Incidence of adverse events (AEs) at timepoint 6
Time Frame: Immediate time of hospital discharge
Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.
Immediate time of hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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