Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.

NCT06261996 | Not Yet Recruiting

• 1 other identifier: henanFSH
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to compare the safety and efficacy of fospropofol and propofol during sedation in invasively mechanically ventilated patients in the Anesthesia Intensive Care Unit (AICU). Specific objectives include the following:

• Evaluate the sedative effects of fospropofol and propofol in invasively mechanically ventilated patients. Compare the sedative effects of the two medications using relevant clinical indicators and scoring tools, such as the Richmond Agitation-Sedation Scale (RASS).
• Compare the safety of fospropofol and propofol during sedation. Monitor medication-related adverse reactions, such as respiratory depression, hypotension, arrhythmias, headache, injection site pain, and assess the differences in adverse reaction incidence between the two medications.
• Compare the characteristics of recovery from sedation between PPD and propofol. Focus on the time from sedation to emergence from sedation and compare the differences in recovery time between the two medications. Participants will be sedated with fospropofol or propofol during invasive mechanical ventilation.

Conditions

Invasive Mechanical Ventilation

Keywords

Fospropofol; Propofol; Invasive mechanical ventilation; sedation

Outcome Measures

Primary Outcomes (1)

• The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions

  The participant's RASS score was assessed by the caregiver and the occurrence of adverse reactions was recorded. Adverse effects include hypotension, bradycardia, tachycardia, agitation, pain at the injection site, nausea and vomiting, edema, fever, anemia, paresthesias, headache, and hypoxemia.

  Admission to the intensive care unit to 2 hours after weaning off the ventilator.

Secondary Outcomes (2)

• Incidence of adverse reactions during the follow-up period

  2 hours after weaning off the ventilator to 24 hours after leaving the intensive care unit.

• Extubation time

  From admission to the intensive care unit to removal of the endotracheal tube

Study Arms (2)

Fospropofol group

ACTIVE COMPARATOR

Fospropofol is administered to patients after admission to the roomat a pumping rate of 1 mg/kg/h.

Drug: Fospropofol

Propofol group

PLACEBO COMPARATOR

Propofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h.

Drug: Fospropofol

Interventions

Fospropofol DRUG

Fospropofol is administered after admission to the room at a pumping rate of 1 mg/kg/h.

Also known as: fospropofol disodium

Fospropofol group; Propofol group

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years old
• Intubation and mechanical ventilation \<12h before enrollment
• Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU).
• Signed informed consent

You may not qualify if:

• parturient, childbirth or lactating mothers
• acute severe neurological disease or coma
• chronic renal failure
• previous mechanical ventilation \>12h
• severe liver dysfunction (Child-Pugh score C)
• BMI \>30kg/m2 (\>90kg)
• dying

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Interventions

fospropofol

Study Officials

• Jiaqiang Q Zhang, M.D

  Henan Provincial People's Hospital

  STUDY CHAIR

Central Study Contacts

Jiaqiang Q Zhang, M.D

CONTACT

0371 65580728; hnmzxh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 15, 2024
• Study Start: February 12, 2024
• Primary Completion: January 15, 2025
• Study Completion: January 15, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02