Study on Pharmacokinetics of Single Injection of Ciprofol in Patients With Moderate to Severe Hypoproteinemia

Xie Kangjie

Status and phase: Completed; Phase 4

Conditions: Ciprofol; Hypoproteinemia; Pharmacokinetics

Treatments: Drug: ciprofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06425757

IRB-2024-315(IIT)

Details and patient eligibility

About

Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

36 participants in 3 patient groups

Severe Hypoproteinemia

Other group

Description:

Blood albumin concentration≤30g/L

Treatment:

Drug: ciprofol

Moderate Hypoproteinemia

Other group

Description:

Blood albumin concentration 30g/L-40g/L

Treatment:

Drug: ciprofol

Normal plasma albumin

Other group

Description:

Blood albumin concentration \>40g/L

Treatment:

Drug: ciprofol