Back to resultsEfficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients
Primary Purpose
Critical Illness
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Fospropofol disodium for injection
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Deep sedation, Fospropofol, Propofol, Intensive care unit
Eligibility 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.
Sites / Locations
- Wuhan Union HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fospropofol disodium for injection
Propofol
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The percentage of time in the target sedation range without rescue sedation
The percentage of time in the target sedation range without rescue sedation
Secondary Outcome Measures
Adverse events
Incidence rate of adverse events
7-day ventilator free time
7-day ventilator free time
Success rate of extubation within 7 days
Success rate of extubation within 7 days
Length of ICU stay
Length of ICU stay
28-day mortality
28-day mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05870514
Brief Title
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients
Official Title
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xiaobo Yang, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Deep sedation, Fospropofol, Propofol, Intensive care unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fospropofol disodium for injection
Arm Type
Experimental
Arm Description
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.
Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fospropofol disodium for injection
Intervention Description
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
Intervention Name(s)
Propofol
Intervention Description
Propofol
Primary Outcome Measure Information:
Title
The percentage of time in the target sedation range without rescue sedation
Description
The percentage of time in the target sedation range without rescue sedation
Time Frame
From start of study to 48 hours
Secondary Outcome Measure Information:
Title
Adverse events
Description
Incidence rate of adverse events
Time Frame
From start of study to 48 hours
Title
7-day ventilator free time
Description
7-day ventilator free time
Time Frame
From start of study to 7 days
Title
Success rate of extubation within 7 days
Description
Success rate of extubation within 7 days
Time Frame
From start of study to 7 days
Title
Length of ICU stay
Description
Length of ICU stay
Time Frame
From start of study to 28 days
Title
28-day mortality
Description
28-day mortality
Time Frame
From start of study to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaobo Yang
Phone
13720311349
Email
want.tofly@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
You Shang
Phone
15972127819
Email
you_shanghust@163.com
Facility Information:
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You Shang, Prof.
Phone
15972127819
Email
you_shanghust@163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of Fospropofol Disodium Versus Propofol for Deep Sedation in Critically Ill Patients
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