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

Elderly Patients Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06251999
• Other study ID #: XWANG
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: February 2024
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: August 31, 2028
• Est. primary completion date: May 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly Patients

Intervention

Drug:
• fospropofol sedation
Fospropofol sedation for same-day bidirectional endoscopy in elderly patients
• Propofol
propofol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Immediate time after sedation emergence
Secondary	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;	Immediate time after sedation emergence
Secondary	Time to patient discharge	Time to patient discharge	Immediate time of hospital discharge
Secondary	Endoscopist's satisfaction questionnaire	Endoscopist's satisfaction	Immediate time after sedation procedure completion
Secondary	Patient's satisfaction questionnaire	Patient's satisfaction	Immediate time of hospital discharge
Secondary	The top-up frequency and dosage of sedative medications	The top-up frequency and dosage of sedative medications	Immediate time after sedation emergence
Secondary	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.	baseline (Prior to sedation)
Secondary	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.	Intraoperative (during sedation)
Secondary	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.	Intraoperative (the timepoint of sedation emergence)
Secondary	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.	15 min in post-anesthesia care unit
Secondary	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.	30 min in post-anesthesia care unit
Secondary	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.	Immediate time of hospital discharge