Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients

Phase 2

Recruiting

• Conditions: Critical Illness
• Interventions: Drug: Fospropofol disodium for injection; Drug: Propofol

• Registration Number: NCT05870514
• Lead Sponsor: Xiaobo Yang, MD

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for deep sedation in mechanically ventilated ICU patients.

Detailed Description

This is a randomized, open-label, small sample study using fospropofol disodium and propofol for deep sedation in mechanically ventilated ICU patients. Subjects are randomized to different treatment groups (including 1 for fospropofol disodium and 1 for propofol). Remifentanil is co-administered with fospropofol or propofol. Efficacy and safety profiles of fospropofol disodium and propofol are to be monitoted.

Study Timeline

• Study First Submitted: 2023-05-12
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-23
• Study Start: 2023-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-01
• Last Update Posted: 2023-07-05
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 18 and ≤ 80 years; Expected to require deep sedation ≥8 hours; Requirement for deep sedation (a Narcotrend index between 13 and 64).

Exclusion Criteria

• Body mass index (BMI) <18 or >30 kg/m2; Contraindicate or allergic to study drugs; Moribund state; Expected to have a general anesthesia within 8 hours; Myasthenia gravis; Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C); Chronic kidney disease with glomerular filtration rate (GFR) < 29 ml/min/1.73m2; Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; Acute severe neurological disorder and any other condition interfering with RASS assessment; Pregnancy or lactation; Unstable angina; Acute myocardial infarction; Left ventricular ejection fraction less than 30%; Heart rate less than 50 beats/min; Second- or third-degree heart block in the absence of a pacemaker; Alcohol abuse or drug abuse.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fospropofol disodium for injection	Fospropofol disodium for injection	Patients in the experimental group received fospropofol disodium for injection at an initial infusion rate of 10 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.
Propofol	Propofol	Patients in the active comparator group received propofol at an initial infusion rate of 3 mg/kg/h and adjusted to maintain a Narcotrend index between 13 and 64.

Primary Outcome Measures

Name	Time	Method
The percentage of time in the target sedation range without rescue sedation	From start of study to 48 hours	The percentage of time in the target sedation range without rescue sedation

Secondary Outcome Measures

Name	Time	Method
7-day ventilator free time	From start of study to 7 days	7-day ventilator free time
Length of ICU stay	From start of study to 28 days	Length of ICU stay
28-day mortality	From start of study to 28 days	28-day mortality
Adverse events	From start of study to 48 hours	Incidence rate of adverse events
Success rate of extubation within 7 days	From start of study to 7 days	Success rate of extubation within 7 days

Trial Locations

Locations (1)

Wuhan Union Hospital; 🇨🇳 Wuhan, Hubei, China