Efficacy and Safety of Fospropofol Disodium Versus Propofol for Sedation in Mechanically Ventilated ICU Patients

NCT05491278 | Completed Phase 2

• 1 other identifier: WUHICU202206
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for sedation in mechanically ventilated ICU patients.

Conditions

Critical Illness

Keywords

Fospropofol; Propofol; Sedation; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Percentage of time spent reaching sedation goals

  Proportion of RASS assessment time points for subjects meeting target sedation levels among all RASS assessment time points during study drug administration without rescue sedation.

  Within 7 days of the study began

Secondary Outcomes (7)

• Invasive ventilator free time within 7 days

  Within 7 days of the study began

• Rate of successful extubation within 7 days

  Within 7 days of the study began

• Incidence of unexpected extubation

  Within 7 days of the study began

• Proportion of delirium in the ICU

  During ICU stay

• Non-ICU survival time within 28 days

  Within 28 days of the study began

Study Arms (2)

Fospropofol disodium for injection

EXPERIMENTAL

Fospropofol disodium continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia.The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.

Drug: Fospropofol disodium for injection

propofol

ACTIVE COMPARATOR

Propofol continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for analgesia. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.

Drug: Propofol

Interventions

Fospropofol disodium for injection DRUG

Fospropofol disodium for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.

Also known as: Remifentanil

Fospropofol disodium for injection

Propofol DRUG

Propofol for injection continuous infusion to reach a RASS score of -3 to 0. Remifentanil continuous infusion of 4 to 9 ug/kg/h for. The dosage adjustment plan was determined by the attending physician. Whether to use other sedative drugs is up to the attending physician.

Also known as: Remifentanil

propofol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged \>= 18 and \<= 75 years; Endotracheal intubated; Patients currently on mechanical ventilation \<= 96 hours and expected to be mechanically ventilated \>= 24 hours; Demand for light/moderate sedation (a RASS score of -3 to 0).

You may not qualify if:

• Informed Consent is unsigned； Participated in any other interventional research within 3 months; Tracheostomy; BMI \<= 18 and \>= 35 kilograms per square meter Pregnant; Lactant; Known or suspected allergy to various components of the study drug or to opioids and their salvage drugs, or other diseases (such as pancreatitis associated with hyperlipidemia) for which lipid emulsion should not be used; Patients who cannot be evaluated for RASS for various reasons (such as mental illness, acquired or congenital mental retardation, deafness, severe neuromuscular disease, Parkinson's disease, Huntington's disease, Alzheimer's disease, cerebrovascular disease, coma, or severe cognitive impairment due to structural diseases such as stroke, intracranial hemorrhage, head injury, malignancy, hypoxic brain injury, or cerebral edema); Patients with an expected survival period of less than 48 hours; Severe hepatic insufficiency (CTP score is 10-15 points); Chronic kidney disease (CKD grade 3 above); Unstable angina pectoris or acute myocardial infarction; Left ventricular ejection fraction \<= 30%; Heart rate \< 50bpm(intravenous pumping of isoproterenol \<4ug/min, heart rate ≥50bpm may not be excluded); Type 2 second-degree or third-degree atrioventricular block (except those implanted a pacemaker); Two vasoconstrictors are used to maintain SBP above 90mmHg after sufficient fluid resuscitation; Myasthenia gravis; Patients with a history of drug abuse, drug abuse, alcohol abuse and long-term use of psychotropic drugs within 2 years before the screening period. Binge drinking is defined as regular drinking more than 14 times per week (1 time = 150ml of wine or 360ml of beer or 45ml of spirits);

Sponsors & Collaborators

• Xiaobo Yang, MD: lead

Study Sites (1)

Department of Critical Care Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Location

MeSH Terms

Conditions

Critical Illness

Interventions

fospropofol; Injections; Remifentanil; Propofol

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

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: August 5, 2022
• First Posted: August 8, 2022
• Study Start: August 10, 2022
• Primary Completion: June 15, 2023
• Study Completion: September 10, 2023
• Last Updated: September 21, 2023

Record last verified: 2022-09

Locations

CN (1)