NCT05870514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

9 months

First QC Date

May 12, 2023

Last Update Submit

July 1, 2023

Conditions

Critical Illness

Keywords

Deep sedationFospropofolPropofolIntensive care unit

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Adverse events

    From start of study to 48 hours

  • 7-day ventilator free time

    From start of study to 7 days

  • Success rate of extubation within 7 days

    From start of study to 7 days

  • Length of ICU stay

    From start of study to 28 days

  • 28-day mortality

    From start of study to 28 days

Study Arms (2)

Fospropofol disodium for injection

EXPERIMENTAL

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.

Drug: Fospropofol disodium for injection

Propofol

ACTIVE COMPARATOR

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.

Drug: Propofol

Interventions

Fospropofol disodium for injectionDRUG

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.

Fospropofol disodium for injection
PropofolDRUG

Propofol

Propofol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (1)

  • Gao X, Gao C, Fang X, Ren L, Zhang H, Tang Y, Yuan Y, Qi H, Shu H, Zou X, Yang X, Shang Y. Fospropofol disodium versus Propofol for deep sedation in critically ill patients: a randomized pilot study. BMC Anesthesiol. 2025 Apr 10;25(1):166. doi: 10.1186/s12871-025-03025-x.

    PMID: 40211146DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

fospropofolInjectionsPropofol

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Xiaobo Yang

CONTACT

13720311349want.tofly@aliyun.com

You Shang

CONTACT

15972127819you_shanghust@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 12, 2023

First Posted

May 23, 2023

Study Start

June 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

CN(1)