AzTrials
AzTrials

Elderly PatientsPhase 4NCT06251999

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

A Phase 4 study testing fospropofol sedation and Propofol in people with Elderly Patients, run by Shanghai 6th People's Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Elderly Patients
What is being tested?
fospropofol sedation and Propofol
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 31 Aug 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

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

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.

Being tested
fospropofol sedation, Propofol
Keywords
fospropofol, propofol, sedation, elderly, bidirectional endoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fospropofol sedationDrug

    Fospropofol sedation for same-day bidirectional endoscopy in elderly patients

  • PropofolDrug

    propofol

Study groups in NCT06251999
Study groupRoleWhat they receive
fospropofolExperimentalNot described
Receives: Drug: fospropofol sedation
propofolPlacebo comparatorNot described
Receives: Drug: Propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Immediate time after sedation emergence

Secondary outcomes (12)

  1. The time to successful induction of sedation

    the time counted from the start of drug administration to the achievement of a sedation score (MOAA/S ) ≤ 1

    Measured: Immediate time after sedation emergence

  2. Time to being fully alert

    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;

    Measured: Immediate time after sedation emergence

  3. Time to patient discharge

    Time to patient discharge

    Measured: Immediate time of hospital discharge

  4. Endoscopist's satisfaction questionnaire

    Endoscopist's satisfaction

    Measured: Immediate time after sedation procedure completion

  5. Patient's satisfaction questionnaire

    Patient's satisfaction

    Measured: Immediate time of hospital discharge

  6. The top-up frequency and dosage of sedative medications

    The top-up frequency and dosage of sedative medications

    Measured: Immediate time after sedation emergence

  7. Incidence of adverse events (AEs) at timepoint 1

    Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.

    Measured: baseline (Prior to sedation)

  8. Incidence of adverse events (AEs) at timepoint 2

    Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.

    Measured: Intraoperative (during sedation)

  9. Incidence of adverse events (AEs) at timepoint 3

    Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.

    Measured: Intraoperative (the timepoint of sedation emergence)

  10. Incidence of adverse events (AEs) at timepoint 4

    Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.

    Measured: 15 min in post-anesthesia care unit

  11. Incidence of adverse events (AEs) at timepoint 5

    Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.

    Measured: 30 min in post-anesthesia care unit

  12. Incidence of adverse events (AEs) at timepoint 6

    Episodes of desaturation, severe desaturation (SpO2 < 90%), hypotension, severe hypotension (decrease in mean blood pressure ≥30% of baseline), and bradycardia.

    Measured: Immediate time of hospital discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2024
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06251999
Sponsor's protocol ID
XWANG
Status last verified
Feb 2024
First submitted
21 Jan 2024
Last updated
9 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing fospropofol sedation and Propofol in people with Elderly Patients, run by Shanghai 6th People's Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The success rate of same-day bidirectional endoscopy (time frame: Immediate time after sedation emergence). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06251999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in