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

September 26, 2025 updated by: Xie Kangjie
Blood concentrations of Ciprofol were measured at different time points after single injection in patients with hypoproteinemia

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (Actual)

36

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejang
      • Hangzhou, Zhejang, China, 310000
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 Names:
  • Si Shuning
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 Names:
  • Si Shuning
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
Other Names:
  • Si Shuning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood concentrations at different time points after a single injection
Time Frame: 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
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
Time Frame: Day 1
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
Time Frame: Day 1
From the time the drug was administered to the time the patient lost consciousness
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xie Kangjie

Investigators

  • Study Director: XIE Kangjie, doctoral, Zhejiang Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2024

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

August 30, 2025

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 (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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