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)
• Status: Recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Hypoproteinemia
• Pharmacokinetics

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