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

Phase 4

Recruiting

• Conditions: Hypoproteinemia; Pharmacokinetics; Ciprofol
• Interventions: Drug: ciprofol

• Registration Number: NCT06425757
• Lead Sponsor: Xie Kangjie

Brief Summary

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 Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-05-09
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Hypoproteinemia	ciprofol	Blood albumin concentration≤30g/L
Normal plasma albumin	ciprofol	Blood albumin concentration \>40g/L
Moderate Hypoproteinemia	ciprofol	Blood albumin concentration 30g/L-40g/L

Primary Outcome Measures

Name	Time	Method
Blood concentrations at different time points after a single injection	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

Secondary Outcome Measures

Name	Time	Method
Onset time of ciprofol in patients with hypoproteinemia	Day 1	The time it takes for the blood concentration of a drug to reach the clinically active concentration level from zero
Effect time of ciprofol in patients with hypoproteinemia	Day 1	From the time the drug was administered to the time the patient lost consciousness

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejang, China