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NCT06425757 Clinical Trial

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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06425757
Other study ID # IRB-2024-315(IIT)
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2024
Est. completion date December 30, 2024

Study information
Verified date May 2024
Source Zhejiang Cancer Hospital
Contact XIE Kangjie, doctoral
Phone 13516721870
Email xiekj@zjcc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 36
Est. completion date December 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Zhejiang Cancer Hospital Hangzhou Zhejang

Sponsors (1)
Lead Sponsor Collaborator
Xie Kangjie

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Effect time of ciprofol in patients with hypoproteinemia From the time the drug was administered to the time the patient lost consciousness Day 1
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