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

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

Study Overview

• Status: Recruiting
• Conditions: Pharmacokinetics; Hypoproteinemia; Ciprofol
• Intervention / Treatment: Drug: ciprofol

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: XIE Kangjie, doctoral; Phone Number: 13516721870; Email: xiekj@zjcc.org.cn

Study Locations

• China
  • Zhejang
    • Hangzhou, Zhejang, China, 310000
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: XIE Kangjie, MD; Phone Number: 13516721870; Email: xiekj@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Severe Hypoproteinemia; Blood albumin concentration≤30g/L	Drug: ciprofol; 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
Other: Moderate Hypoproteinemia; Blood albumin concentration 30g/L-40g/L	Drug: ciprofol; 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
Other: Normal plasma albumin; Blood albumin concentration >40g/L	Drug: ciprofol; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1
Effect time of ciprofol in patients with hypoproteinemia	From the time the drug was administered to the time the patient lost consciousness	Day 1

Collaborators and Investigators

• Sponsor: Xie Kangjie
• Investigators: Study Director: XIE Kangjie, doctoral, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 22, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Protein Disorders; Hypoproteinemia
• Other Study ID Numbers: IRB-2024-315(IIT)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No