HypoproteinemiaPhase 4NCT06425757
Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia
A Phase 4 study testing ciprofol in people with Hypoproteinemia and Pharmacokinetics, run by Xie Kangjie at 1 site in China.
Trial summary
Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypoproteinemia, Pharmacokinetics, Ciprofol
- What is being tested?
- ciprofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 4 Apr 2024to 30 Aug 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with moderate to severe hypoproteinemia (albumin < 30g/L, protein detection time uniformly within three days before surgery）
- Weight greater than 45kg, BMI20-24
- The ASA rating is Class I or Class II
Who cannot join
- Severe liver dysfunction
- Severe renal dysfunction
- Patients with ASA grade III and above
- Known allergy to eggs, soy products, opioids and their relief drugs, propofol
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia
Read the detailed description
This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood.
- Conditions
- Hypoproteinemia, Pharmacokinetics, Ciprofol
- Being tested
- ciprofol
- Medical subject headings
- Hypoproteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciprofolDrug
Also called Si Shuning
Patients who intended to undergo elective surgery under general anesthesia were induced by a single intravenous injection of 0.3mg/kg and ciprofol, and the experimental drug was manually injected by CVC within 30s. 2ml of venous blood was collected before and after administration 0.5min, 1min, 2min, 3min, 5min, 8min, 15min 30min, 1h, 2h and 4h respectively. The concentration of cyclopofol in blood was measured
| Study group | Role | What they receive |
|---|---|---|
| Severe Hypoproteinemia | Other | Blood albumin concentration≤30g/L Receives: Drug: ciprofol |
| Moderate Hypoproteinemia | Other | Blood albumin concentration 30g/L-40g/L Receives: Drug: ciprofol |
| Normal plasma albumin | Other | Blood albumin concentration >40g/L Receives: Drug: ciprofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood concentrations at different time points after a single injection
Blood concentration of ciprofol
Measured: Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours
Secondary outcomes (2)
Onset time of ciprofol in patients with hypoproteinemia
The time it takes for the blood concentration of a drug to reach the clinically active concentration level from zero
Measured: Day 1
Effect time of ciprofol in patients with hypoproteinemia
From the time the drug was administered to the time the patient lost consciousness
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start4 Apr 2024
- Primary completion30 Apr 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoproteinemiaStudies 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xie Kangjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xie Kangjie, Zhejiang Cancer Hospital
- Investigators
- XIE Kangjie, doctoral, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425757
- Sponsor's protocol ID
- IRB-2024-315(IIT)
- Status last verified
- Mar 2025
- First submitted
- 9 May 2024
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia
- ClinicalTrials.gov ID
- NCT06425757
- Acronym / sponsor ID
- IRB-2024-315(IIT)
- Conditions
- Hypoproteinemia, Pharmacokinetics, Ciprofol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Xie KangjieUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 22 May 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.
Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia
Detailed description
This study was a single-center, interventional clinical study. Patients with different plasma albumin levels were selected before surgery and induced by a single injection of Ciprofol at a depth of 0.3 mg/kg. 2ml of venous blood was collected before and 0.5, 1, 2, 3, 5, 8, 15, 30min, 1h, 2h and 4h after administration. The pharmacokinetics of Ciprofol were studied by measuring the concentration of Ciprofol in blood.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Severe Hypoproteinemia | Other | Drug: ciprofolBlood albumin concentration≤30g/L |
| Moderate Hypoproteinemia | Other | Drug: ciprofolBlood albumin concentration 30g/L-40g/L |
| Normal plasma albumin | Other | Drug: ciprofolBlood albumin concentration >40g/L |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with moderate to severe hypoproteinemia (albumin < 30g/L, protein detection time uniformly within three days before surgery）
- Weight greater than 45kg, BMI20-24
- The ASA rating is Class I or Class II
Key exclusion criteria (5 listed)
- Severe liver dysfunction
- Severe renal dysfunction
- Patients with ASA grade III and above
- Known allergy to eggs, soy products, opioids and their relief drugs, propofol
- Emergency surgery
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 |
|---|---|---|
| ciprofolAlso: Si ShuningPatients who intended to undergo elective surgery under general anesthesia were induced by a single intravenous injection of 0.3mg/kg and ciprofol, and the experimental drug was manually injected by CVC within 30s. 2ml of venous blood was collected before and after administration 0.5min, 1min, 2min, 3min, 5min, 8min, 15min 30min, 1h, 2h and 4h respectively. The concentration of cyclopofol in blood was measured | Drug | Moderate Hypoproteinemia, Normal plasma albumin, Severe Hypoproteinemia |
Primary outcome
Blood concentrations at different time points after a single injection
Time frame: Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours
Blood concentration of ciprofol
2 secondary outcomes
Onset time of ciprofol in patients with hypoproteinemia
Time frame: Day 1
Effect time of ciprofol in patients with hypoproteinemia
Time frame: Day 1
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 1 Oct 2025.
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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.
XIE Kangjie, doctoral study director
Zhejiang Cancer 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 ciprofol in people with Hypoproteinemia and Pharmacokinetics, run by Xie Kangjie 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 3 inclusion and 5 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 1 Oct 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?
Blood concentrations at different time points after a single injection (time frame: Before administration, after administration 0.5 minute, 1 minute, 2 minutes, 3 minutes, 5 minutes, 8 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours). 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 1 Oct 2025.