Overview

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

Status:
Not yet recruiting

Trial end date:
2024-06-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Xiaobo Yang, MD

Treatments:

Fospropofol
Propofol

Criteria

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.