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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Fospropofol disodium for injection

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

Propofol

Interventions

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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.

Intervention Type DRUG

Propofol

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No