Clinical trial NCT06251999: Efficacy and Safety of Fospropofol for Same-day Bidirectional Endoscopy in Elderly Patients
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Elderly Patients
Keywords: fospropofol
propofol
sedation
elderly
bidirectional endoscopy
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 256
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The success rate of same-day bidirectional endoscopy
timeFrame: Immediate time after sedation emergence
Secondary outcomes:
measure: The time to successful induction of sedation
timeFrame: Immediate time after sedation emergence
measure: Time to being fully alert
timeFrame: Immediate time after sedation emergence
measure: Time to patient discharge
timeFrame: Immediate time of hospital discharge
measure: Endoscopist's satisfaction questionnaire
timeFrame: Immediate time after sedation procedure completion
measure: Patient's satisfaction questionnaire
timeFrame: Immediate time of hospital discharge
measure: The top-up frequency and dosage of sedative medications
timeFrame: Immediate time after sedation emergence
measure: Incidence of adverse events (AEs) at timepoint 1
timeFrame: baseline (Prior to sedation)
measure: Incidence of adverse events (AEs) at timepoint 2
timeFrame: Intraoperative (during sedation)
measure: Incidence of adverse events (AEs) at timepoint 3
timeFrame: Intraoperative (the timepoint of sedation emergence)
measure: Incidence of adverse events (AEs) at timepoint 4
timeFrame: 15 min in post-anesthesia care unit
measure: Incidence of adverse events (AEs) at timepoint 5
timeFrame: 30 min in post-anesthesia care unit
measure: Incidence of adverse events (AEs) at timepoint 6
timeFrame: Immediate time of hospital discharge
Other outcomes:
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