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Completed

NCT Number: NCT06425757

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

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Key information

Conditions

Hypoproteinemia Blood Protein Disorders Ciprofol Hematologic Diseases Hemic and Lymphatic Diseases Pharmacokinetics

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Zhejiang Cancer Hospital

Hangzhou, Zhejang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Si Shuning

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Xie Kangjie

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 22, 2024
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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