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

NCT ID: NCT06261996

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2025-01-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Fospropofol group

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

Group Type: ACTIVE_COMPARATOR

Fospropofol

Intervention Type: DRUG

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

Propofol group

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

Group Type: PLACEBO_COMPARATOR

Fospropofol

Intervention Type: DRUG

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

Interventions

Fospropofol

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

Intervention Type: DRUG

Other Intervention Names

fospropofol disodium

Eligibility Criteria

Inclusion Criteria

1. Aged 18-65 years old

2. Intubation and mechanical ventilation <12h before enrollment

3. Expected to require continuous invasive ventilation and sedation less than 6h after admission to anesthesia intensive care unit (AICU).

4. Signed informed consent

Exclusion Criteria

1. parturient, childbirth or lactating mothers

2. acute severe neurological disease or coma

3. chronic renal failure

4. previous mechanical ventilation >12h

5. severe liver dysfunction (Child-Pugh score C)

6. BMI >30kg/m2 (>90kg)

7. dying

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiaqiang Q Zhang, M.D

Role: STUDY_CHAIR

Henan Provincial People's Hospital

Central Contacts

Jiaqiang Q Zhang, M.D

Role: CONTACT

hnmzxh@163.com

0371 65580728 ext. +86

Other Identifiers

henanFSH

Identifier Type: -

Identifier Source: org_study_id