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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870514
• Other study ID #: WUHICU202304
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: Wuhan Union Hospital, China
• Contact: Xiaobo Yang
• Phone: 13720311349
• Email: want.tofly[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiaobo Yang, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of time in the target sedation range without rescue sedation	The percentage of time in the target sedation range without rescue sedation	From start of study to 48 hours
Secondary	Adverse events	Incidence rate of adverse events	From start of study to 48 hours
Secondary	7-day ventilator free time	7-day ventilator free time	From start of study to 7 days
Secondary	Success rate of extubation within 7 days	Success rate of extubation within 7 days	From start of study to 7 days
Secondary	Length of ICU stay	Length of ICU stay	From start of study to 28 days
Secondary	28-day mortality	28-day mortality	From start of study to 28 days