Elective SurgeryPhase 4NCT06344325
ED90 of Fospropofol Disodium in Induction and Maintenance of Anesthesia
A Phase 4 study testing fospropofol in people with Elective Surgery, run by Tongji Hospital at 1 site in China.
Trial summary
Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Elective Surgery
- What is being tested?
- fospropofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 28 Feb 2025
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-80 years old, elective surgery under general anesthesia.
- ASA I-II;
- Surgical duration>30 minutes;
- Sign an informed consent form.
Who cannot join
- American Society of Anesthesiologists(ASA)≥ III;
- Body mass index (BMI)<18 kg/m2 or>30 kg/m2;
- Individuals with a history or potential history of drug abuse or alcohol dependence;
- Preoperative use of sedative or analgesic drugs;
- Individuals with severe liver and kidney dysfunction;
- Individuals who are allergic or potentially allergic to propofol and lipids;
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- The types of surgeries that directly affect hemodynamics, such as large vessel surgery and other surgical procedures;
- Patients with abnormal coagulation function, endocrine disorders, or other factors affecting hemodynamic status;
- Participants in other clinical studies within the past 3 months;
- researchers deemed it inappropriate for participants to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages
Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia
Read the detailed description
As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.
- Conditions
- Elective Surgery
- Being tested
- fospropofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fospropofolDrug
Also called fospropofol disodium
The initial dose of fospropofol disodium in the youth group is 15mg/kg,the middle-aged group is 10mg/kg, the elderly group is 7.5mg/kg, and the concentration of adjacent intervals is 0.5mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Youth group | Experimental | Youth group (18-45 years old) Receives: Drug: fospropofol |
| middle-aged group | Experimental | middle-aged group (46-65 years old) Receives: Drug: fospropofol |
| elderly group | Experimental | elderly group (66-80 years old) Receives: Drug: fospropofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedation score
Sedation score (MOAA/S)
Measured: 1 day
Secondary outcomes (1)
Postoperative adverse reactions
Postoperative adverse reactions such as Hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 May 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective SurgeryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aijun xu, Tongji Hospital
- Investigators
- aihua Du, Dr., Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344325
- Sponsor's protocol ID
- EDPP
- Status last verified
- Aug 2025
- First submitted
- 26 Mar 2024
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 90% Effective Dose Study of Fospropofol Disodium in Induction and Maintenance of Anesthesia in Adults of Different Ages
- ClinicalTrials.gov ID
- NCT06344325
- Acronym / sponsor ID
- EDPP
- Conditions
- Elective Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 3 Apr 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.
Exploring the 90% effective dose (ED90) of fospropofol disodium in induction and maintenance of anesthesia in adults of different ages, providing more clinical evidence for the application of fospropofol disodium in clinical anesthesia
Detailed description
As a newly marketed sedative hypnotic agent, fospropofol disodium is currently the only water-soluble precursor drug of propofol in China. It has the characteristics of long duration of action, low incidence of injection pain, respiratory and circulatory system related adverse events, and no lipid metabolism related adverse reactions, providing anesthesiologists with another sedative option during surgery. However, there are currently few clinical observation studies on this drug, and there have been no reports on its effective dosage in different age groups. Therefore, this study aims to observe the 90% effective dose (ED90) in anesthesia induction and maintenance in adults of different ages, providing effective clinical evidence for its application in clinical anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Youth group | Experimental | Drug: fospropofolYouth group (18-45 years old) |
| middle-aged group | Experimental | Drug: fospropofolmiddle-aged group (46-65 years old) |
| elderly group | Experimental | Drug: fospropofolelderly group (66-80 years old) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18-80 years old, elective surgery under general anesthesia.
- ASA I-II;
- Surgical duration>30 minutes;
- Sign an informed consent form.
Key exclusion criteria (10 listed)
- American Society of Anesthesiologists(ASA)≥ III;
- Body mass index (BMI)<18 kg/m2 or>30 kg/m2;
- Individuals with a history or potential history of drug abuse or alcohol dependence;
- Preoperative use of sedative or analgesic drugs;
- Individuals with severe liver and kidney dysfunction;
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 disodiumThe initial dose of fospropofol disodium in the youth group is 15mg/kg,the middle-aged group is 10mg/kg, the elderly group is 7.5mg/kg, and the concentration of adjacent intervals is 0.5mg/kg. | Drug | Youth group, elderly group, middle-aged group |
Primary outcome
Sedation score
Time frame: 1 day
Sedation score (MOAA/S)
1 secondary outcome
Postoperative adverse reactions
Time frame: 1 day
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 14 Aug 2025.
- Individual participant dataSharing planned: No
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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.
aihua Du, Dr. study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing fospropofol in people with Elective Surgery, run by Tongji 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 10 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 14 Aug 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Sedation score (time frame: 1 day). 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 14 Aug 2025.