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NCT Number: NCT06251999

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

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.

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Key information

Conditions

Elderly Patients

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fospropofol sedation

Drug

Fospropofol sedation for same-day bidirectional endoscopy in elderly patients

Propofol

Drug

propofol

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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;

  3. Time to patient discharge

    Time frame: Immediate time of hospital discharge

    Time to patient discharge

  4. Endoscopist's satisfaction questionnaire

    Time frame: Immediate time after sedation procedure completion

    Endoscopist's satisfaction

  5. Patient's satisfaction questionnaire

    Time frame: Immediate time of hospital discharge

    Patient's satisfaction

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Shanghai 6th People's Hospital

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 9, 2024
Registry last updated
Feb 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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