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

NCT06425757 | Completed Phase 4

• 1 other identifier: IRB-2024-315(IIT)
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoproteinemia; Pharmacokinetics; Ciprofol

Outcome Measures

Primary Outcomes (1)

• Blood concentrations at different time points after a single injection

  Blood concentration of ciprofol

  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

  Day 1

• Effect time of ciprofol in patients with hypoproteinemia

  Day 1

Study Arms (3)

Severe Hypoproteinemia

OTHER

Blood albumin concentration≤30g/L

Drug: ciprofol

Moderate Hypoproteinemia

OTHER

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

Drug: ciprofol

Normal plasma albumin

OTHER

Blood albumin concentration \>40g/L

Drug: ciprofol

Interventions

ciprofol DRUG

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

Also known as: Si Shuning

Moderate Hypoproteinemia; Normal plasma albumin; Severe Hypoproteinemia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xie Kangjie: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejang, 310000, China

Location

MeSH Terms

Conditions

Hypoproteinemia

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenol

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• XIE Kangjie, doctoral

  Zhejiang Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 22, 2024
• Study Start: April 4, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 30, 2025
• Last Updated: October 1, 2025

Record last verified: 2025-03

Locations

CN (1)