Invasive Mechanical VentilationNCT06261996
Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation.
A study testing Fospropofol in people with Invasive Mechanical Ventilation, run by Henan Provincial People's Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Invasive Mechanical Ventilation
- What is being tested?
- Fospropofol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2024to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation in Anesthesiology Intensive Care Unit: A Preliminary Study
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
- Being tested
- Fospropofol
- Keywords
- Fospropofol, Propofol, Invasive mechanical ventilation, sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FospropofolDrug
Also called fospropofol disodium
Fospropofol is administered after admission to the room at a pumping rate of 1 mg/kg/h.
| Study group | Role | What they receive |
|---|---|---|
| Fospropofol group | Active comparator | Fospropofol is administered to patients after admission to the roomat a pumping rate of 1 mg/kg/h. Receives: Drug: Fospropofol |
| Propofol group | Placebo comparator | Propofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h. Receives: Drug: Fospropofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Adverse effects include hypotension, bradycardia, tachycardia, agitation, pain at the injection site, nausea and vomiting, edema, fever, anemia, paresthesias, headache, and hypoxemia.
Measured: 2 hours after weaning off the ventilator to 24 hours after leaving the intensive care unit.
Extubation time
The time from admission to the intensive care unit to removal of the endotracheal tube
Measured: From admission to the intensive care unit to removal of the endotracheal tube
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start12 Apr 2024
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiaqiang Q Zhang, M.D, Study chair, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261996
- Sponsor's protocol ID
- henanFSH
- Status last verified
- May 2026
- First submitted
- 8 Feb 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fospropofol vs Propofol During Invasive Mechanical Ventilation in Anesthesiology Intensive Care Unit: A Preliminary Study
- ClinicalTrials.gov ID
- NCT06261996
- Acronym / sponsor ID
- henanFSH
- Conditions
- Invasive Mechanical Ventilation
- Keywords
- Fospropofol, Propofol, Invasive mechanical ventilation, sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fospropofol group | Active comparator | Drug: FospropofolFospropofol is administered to patients after admission to the roomat a pumping rate of 1 mg/kg/h. |
| Propofol group | Placebo comparator | Drug: FospropofolPropofol is administered after admission to the room at a pumping rate of 0.5 mg/kg/h. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-75 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FospropofolAlso: fospropofol disodiumFospropofol is administered after admission to the room at a pumping rate of 1 mg/kg/h. | Drug | Fospropofol group, Propofol group |
Primary outcome
The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions
Time frame: Admission to the intensive care unit to 2 hours after weaning off the ventilator.
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.
2 secondary outcomes
Incidence of adverse reactions during the follow-up period
Time frame: 2 hours after weaning off the ventilator to 24 hours after leaving the intensive care unit.
Extubation time
Time frame: From admission to the intensive care unit to removal of the endotracheal tube
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiaqiang Q Zhang, M.D study chair
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fospropofol in people with Invasive Mechanical Ventilation, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's Richmond Agitation-Sedation Scale (RASS) score and the incidence of adverse reactions (time frame: Admission to the intensive care unit to 2 hours after weaning off the ventilator.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.