Evaluating how Ciprofol behaves in the body after a single injection in patients with low protein levels
Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia
This study is testing how a single injection of Ciprofol works in patients with low protein levels in their blood to better understand how the medication is processed in their bodies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Zhejiang Cancer Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejang) |
| Trial ID | NCT06425757 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the pharmacokinetics of Ciprofol, a medication administered via a single injection, in patients suffering from moderate to severe hypoproteinemia. The study involves measuring blood concentrations of Ciprofol at various time points following administration to understand how the drug is processed in individuals with low plasma albumin levels. Participants are selected based on specific inclusion criteria, and blood samples are collected before and after the injection to analyze the drug's behavior in the body. The findings aim to provide insights into the appropriate use of Ciprofol in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with moderate to severe hypoproteinemia who are scheduled for surgery.
Not a fit: Patients with severe liver or renal dysfunction, or those undergoing emergency surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize the use of Ciprofol in patients with hypoproteinemia, improving their surgical outcomes.
How similar studies have performed: While pharmacokinetic studies are common, this specific investigation into Ciprofol in hypoproteinemic patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Hangzhou, Zhejang
- Zhejiang Cancer Hospital — Hangzhou, Zhejang, China (Recruiting)
Study contacts
- Study coordinator: XIE Kangjie, doctoral
- Email: xiekj@zjcc.org.cn
- Phone: 13516721870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.